Jobs That Crossed My Desk Through Sept
Jobs That Crosssed My Desk Through Nov. 15, 2009
Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.
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Jim Brown Associates
15 Southwind Circle
Marina Bay – The Breakers
Richmond, CA 94804-7405
Phone: (510) 235-4472
e-mail: jim@
SENIOR PRODUCT MANAGER
Company:
An oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. The company is developing its lead product candidate for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been submitted to the U.S. Food and Drug Administration for CML patients with the Bcr-Abl T315I mutation. The corporate strategy is to commercialize the product independently in North America and to establish commercial partnerships in the rest of the world.
Responsibilities
Based in the San Francisco Bay Area, and reporting to the Director of Marketing, the Senior Product Manager will be responsible for planning and executing the North America oncology marketing strategy. This position will build upon all the key elements of the market plan; product positioning, branding, pricing and promotion/medical education for the CML product launch as well as for other oncology indications in the pipeline.
The position has responsibility for developing and managing the product management function and to work in concert with other functional departments to ensure commercial success for the company’s products and services. The Product Manager will take a leadership role in developing key opinion leaders and will establish relationships with the oncology community at large. In addition, the Product Manager position will assist and support the build out of a Sales and Service capability.
Position, Purpose and Responsibilities
Specifically, the Senior Product Manager will be responsible for and participate in the following activities:
• Liaise closely with project teams to address commercial issues
• Develop a product marketing plan for North America
• Identify and establish working relationships with key opinion leaders and key cancer centers
• Develop product forecasts and P & Ls for North America
• Understand local regulatory requirements and their impact on commercial and development strategies
• Develop and maintain expertise on evolving regulatory, pricing and oncology business environment issues
• Develop product brand identity in North America
• Assist in defining health economic and pricing strategy
• Work with manufacturing to optimize distribution and scheduling of product
• Manage publication planning to ensure product positioning and information flow
• Liaise with Clinical Affairs to ensure implementation of Phase IV clinical trials to establish expanded product use
• Manage marketing expenses and ensure fiscal management for all oncology products
• Manage and develop marketing staff to meet the needs of the corporation
• Manage external vendor and patient advocacy relationships relating to marketing activities
Position Requirements
• Bachelor’s degree, preferably in the life sciences. MBA or other advanced degree is desirable
• Minimum of 5-7 years progressive experience in sales and marketing of oncology products to various customer groups
• Product launch experience, preferably in the field of liquid tumors and/or hematology.
• Significant experience setting up and implementing marketing plans, implementing pricing and reimbursement strategies.
• Experience working with clinicians
• Good conceptual, analytical, problem-solving and organization skills
• Excellent interpersonal, communications and presentation skills
• A reputation of being one of the best at his/her peer level, a well-rounded business executive on the basis of technical competence / intelligence, results, interpersonal skills, and general business acumen
• A reputation for consistently meeting objectives and deadlines
• An action-oriented, “hands-on” individual who enjoys challenge; is capable and dedicated to getting the job done with minimal support and direction; must be a “self-starter” who enjoys the challenges of working in a start-up environment.
• A high energy individual, accustomed to a busy work schedule including extensive travel, and works well under pressure
• An assertive, take-charge, proven manager with a strong results orientation, positive “can-do” attitude and a sense of urgency to get things done
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Bill Good
President
EXPO Recruiters
Napa, CA
bgood0802@
SUMMARY: This position will develop and implement manufacturing processes, equipment, and fixtures. Will work as part of a developmental team in developing and implementing new processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
- Create documentation to support new and improved manufacturing processes
- Write and perform process validations
- Perform IQ/OQ/PQ as required on equipment.
- Disposition NCR's and CAPA's as assigned.
- Perform experiments including but not limited to DOE's to characterize and improve processes.
- Provide leadership and direction for more junior engineers in areas of manufacturing engineering and process development.
- Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis.
- Coordinate with the suppliers and external resources needed in developing and implementing new processes.
- Work closely between R&D and Manufacturing to capture and interpret the design intent in order to refine and improve processes.
- Facilitate excellent communications between all team members.
EDUCATION/EXPERIENCE:
-Bachelor degree in chemical engineering or equivalent experience.
-Minimum of five (3) years experience, preferably in a medical device environment.
- Excellent hands-on communication and interpersonal skills
- Experienced in MS Word, Excel, and Project
- Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA).
- Experience with CAD Software (Solid Works & AutoCAD) preferred
Supervisory experience preferred
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FYI. If interested, contact Tim Whiting at 610-263-3030 Ext 4150.
Tim Whiting, Ben Venue Laboratories/Boehringer Ingelheim Recruiting Partner
tim.whiting@
610-263-3030 Ext 4150
PERMANENT OPENING -- Sr. Formulation Scientist - Pharmaceutical Product & Process Development positionat at Ben Venue Laboratories
I am currently searching for candidates for a Senior Formulation Scientist - Pharmaceutical Product and Process Development (PPD) for Ben Venue Laboratories (BVL) for their state-of-the-art pharmaceutical manufacturing facility in Bedford, OH (Cleveland Metropolitan Area).
Ben Venue Laboratories is a subsidiary of Boehringer-Ingelheim (BI).
I work for The RightThing, LLC which is the Recruitment Process Outsourcing (RPO) firm that is doing all of the hiring for BI and their subsidiaries. I work directly with the hiring managers at BVL.
Interested candidates should call me directly at 610-263-3030 ext. 4150 and send their resumes to me at tim.whiting@ as soon as possible.
Some of the responsibilities of the Sr. Formulation Scientist will be to:
- Work within the PPD in BVL Generics. BVL Joint Venture(s) and BVL internal development support for Manufacturing, Process Validation, Quality Assurance/Control and Engineering.
- Develop Small Volume Parenteral products from preformulation through transfer to manufacture
- Be involved in the development and evaluation of proposed formulation, processing procedure and selected container/closure system through pilot batch testing & development stability studies.
- Lead and participate in de-formulation activities to support generic dosage forms
- Serve as technical leader for more junior formulation scientists.
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CONTACT
Steve Jaben, Vice President
Life Sciences Practice
M Squared Consulting Inc.
Office: 949.589.3918
Email: sjaben@
Senior Medical Writer
An M Squared client requires a Senior Medical Writer to prepare a report for the FDA analyzing death related data from clinical studies.
DELIVERABLES
An FDA-ready final report approved by the client's management team.
METHODS & CHARACTERISTICS
The consultant will work with the clinical and regulatory team members to understand the current data and research available around patient population, drug actions, cardiac effects/safety and respiratory effects/safety and develop the report.
The consultant should have deep clinical expertise in respiratory and/or cardiology at the PhD or MD level. S/he should be able to show medical writing examples in cardiology/respiratory which are relative to the deliverable.
The consultant should be familiar with FDA guidance and risk definitions for new drug approvals related to cardiac/respiratory effects/deaths, or understand how to quickly define them.
The consultant should be an expert in mitigating strategies to overcome relative FDA concerns through appropriate report submissions/discussions, labeling and marketing claims.
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CONTACT
For more information contact: hollyv@
Technical Writer San Jose, CA
Do you have experience writing about bio-tech devices or clinical diagnostic and research tools? We would like to talk to you. We're managing a team of writers for an 8-12 month contract updating and existing clinical diagnostic product documentation.
Onsite required in San Jose
Full-time hours required
REQUIREMENTS
• Expert FrameMaker skills
• 3+ years experience writing about bio-tech or clinical diagnostic equipment
• 7+ years of Technical Writing experience
• Able to work independently
• Familiarity with style guides
• Work closely with cross-functional teams
• Communicate status, issues, and risks to project stakeholders
• Ability to meet deliverables
• Knowledge of FDA documentation regulations a plus
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uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, also has a click-by-state job bulletin (biotech-pharma-jobs) for employers/recruiters and job-seekers to post and find pharma jobs, biotech jobs, and other life science jobs for free. The following is a list of recent job postings:
Pharmacy Technician NC
Preclinical Sales Manager home-based or 2 specified locations
JD Edwards CSV Consultants
Senior Pathlogist with MedImmune MD
Scientist with MedImmune MD
Pls go to our job bulletin biotech-pharma-jobs. It’s easy to use the View All Jobs function to find jobs. Pls read the job descriptions carefully. Pls check that there is a reasonable fit and then follow the specified instructions to apply. Pls be sure to mention that you found the job(s) at .
has also launched its one-of-a-kind science eCards called ePharmaCards. Pls also check out our new section of Featured Articles, which contain articles about Biotech Start-up, Careers and Employment, Contract Research, and other topics. Pls also join us at our new linkedin group “Pharma & Life Science Mixer”. We wish you all lots of successes.
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Charles Jo
408.668.4226
charles.jo@
I have job leads for Quality Engineers/Quality Engineering Managers for San Francisco Bay Area medical device company so if you have colleagues looking for new opportunities, please ask them to contact me ASAP for additional information. I'd like to submit top referrals in next 2 days.
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Jeff DeGroot | Sr. Recruiter
Cell: 916 899-4950
Jeff.degroot@
My name is Jeff DeGroot; I am a Senior Recruiter working with Korn/Ferry
- Futurestep. We have been exclusively retained by one of the
world's largest manufacturers of biomedical laboratory instruments to
help them identify qualified candidates interested in a Scientific Sales
Consultant position. I would like to network with you and see if you or
one of your colleagues would be interested in learning more about this
opportunity.
Should you not be interested, feel free to make of this a great
networking opportunity and pass this information along.
Position title: Scientific Sales Consultant -- Full Time
The primary duty of this position is to serve as a subject matter expert
supporting and influencing sales, as well as developing and implementing
solutions.
Here is what we are looking for in the ideal candidate:
1. *Ph.D. in Clinical Laboratory, Pharmaceutical Science or related
field (Must have PhD or extensive experience at Masters Level)***
*2. Highly developed verbal and written communication skills*
*3. Experience in clinical laboratory or pharmaceutical science -
highly desirable. *
*4. In depth knowledge of all technical aspects of clinical
laboratory and testing - highly desirable*
*5. Customer service orientation with timely, organized, accurate and
complete attention to providing technical and scientific consultation***
If you are interested feel free to contact me via email, and send me an
updated copy of your resume.
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John Pandes
Senior Staffing Consultant
Gilead Sciences, Inc.
O: (650) 522-5599
John.Pandes@
Subject: Gilead Sciences is searching for an Associate Director, CMC Regulatory Affairs
Gilead Sciences , located in Foster City, CA is engaged in the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders. Due to our continued growth, Gilead Sciences is currently seeking an Associate Director for our CMC Regulatory Affairs group. This position is based in our corporate headquarter in Foster City, CA. Relocation assistance is available.
You can see the job description posted on our careers page: Associate Director - CMC Regulatory Affairs
If you are interested in this position please contact me to discuss the opportunity. If this is not right for you, perhaps you might be assist me by passing my message along to your network. I would welcome any referrals.
BusinessWeek has ranked Gilead #1 in its 2009 listing of the 50 best-performing companies.
For further information about Gilead, please visit
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David Obad
Managing Partner
NCompass Recruiting Services, LLC
Office: 415.738.7878 x 104
“Helping Navigate Your Medical Device Career”
There has been some movement on the medical device job front. Below are 4 open positions that require experience in one or more of the following areas: EE/Hardware Testing, Mechanical Engineering, and Manufacturing Process Engineering:
· Principal Test Engineer (Manufacturing/Hardware) - experience in the development of automated test equipment (ATE). Located in the Palo Alto area.
· Sr Mechanical Engineer – experience with electro-mechanical actuator design. (background with electric motors is preferred). Located in the Fremont area.
· Sr Manufacturing Process Engineer – experience implementing lean manufacturing, NPI, DOE, and performing fixture redesign. Located in the San Jose area.
· EE Test Engineer – experience conducting integration tests for an electronic medical device product. This position will lead collaboration efforts for requirements analysis and test documentation (including all related Requirements Specification, Design Description, Test Plan and Test Procedures). Software/Firmware background preferred. Located in Los Angeles area.
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Elly Grimaldi at
elly.grimaldi@
Here is a lead, please apply directly to Elly Grimaldi at Map
Pharmaceuticals is hiring for the following positions: send resume to Elly Grimaldi
Sr. Manufacturing Engineer
Director of Manufacturing
Clinical Contract Manager
A/P
Marketing Coordinator
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Contact Darshana V. Nadkarni, Ph.D.at wd_darshana@
I am looking for senior mechanical engineer with 10+ yrs exp with catheter devt and project management skills - in case you get to announce it :). And still looking for Quality Engineer with supplier QE exp.
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mailto:Joy@
Please apply below for immediate consideration:
Direct link to position:
Senior Mechanical Engineer Position Boston Area (Medical Device) **
Immediate Interviews**
Senior Mechanical Engineer - Medical Imaging (Boston)
Position #135 SME on our website. Interviews within 24 hours. Immediate
Start!
Our client manufactures a game-changing medical imaging technology used in
hospitals, imaging centers and private practices world-wide. This mid-stage
start up company uses advanced medical imaging equipment to save lives and
is looking for a senior mechanical engineer (10+ years experience) to play a
critical role in designing, fabricating, and testing the latest medical
imaging technology. The successful senior mechanical engineer will have
extensive knowledge of 3D Solid Modeling, FEA, GD&T, ISO procedures, GMP
requirements and 9001 standards
Primary Responsibilities
* Design radiation detectors, radiation shielding, support structures,
linear motion systems, production tooling and fixtures and production test
equipment for medical imaging devices
* Design, fabrication and testing of prototypes which shall ultimately
be installed in clinical environments
* Comply with regulatory and quality requirements for medical devices
* Conducts design reviews and documentation control so as to satisfy
medical device regulations and harmonized standards for the design history
files.
* Creates detailed engineering specifications, drawings and test
reports
* Develops and facilitates in the execution of system verification
plans for assemblies and test fixtures and tools
* Presentation of results and plans at data reviews and sub-team
meetings, assistance with the running of component, assembly, subsystem &
system-level tests
* Maintain & follow proper ISO procedures and GMP requirements with
special knowledge of 9001 standards
Education Requirements:
* Bachelor's degree in Mechanical Engineering
Position Requirements:
* 10+ years experience in an engineering environment for designing,
specifying, fabricating, assembling, testing, validating, and debugging
machinery, product and manufacturing process
* Extensive knowledge of material properties for metals, optics and
adhesives
* Versed in mechanical properties of computer tomography and nuclear
medical equipment
* Ability to solve complex engineering problems or implement solutions
or processes for manufacturing
* 3D Solid Modeling, FEA, GD&T and CFD
* Excellent written and oral communication skills
$90K - $105K Salary 10+ yrs experience
$105-$120K Salary 20+ yrs experience
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Jobs That Crosssed My Desk Through Nov. 8, 2009
uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, also has a click-by-state job bulletin (job) for employers/recruiters and job-seekers to post and find pharma jobs, biotech jobs, and other life science jobs for free. The following is a list of recent job postings:
Preclinical Sales Manager home-based or 2 specified locations
JD Edwards CSV Consultants
Senior Pathlogist with MedImmune MD
Scientist with MedImmune MD
Pls go to our job bulletin job . It’s easy to use the View All Jobs function to find jobs. Pls read the job descriptions carefully. Pls check that there is a reasonable fit and then follow the specified instructions to apply. Pls be sure to mention that you found the job(s) at .
is also launching its one-of-a-kind science eCards. Pls be free to check them out. Pls also join us at our new linkedin group “Pharma & Life Science Mixer”. We wish you all lots of successes.
***********************************************************************************************
New Career Opportunities at careers.
Pfizer, Astellas, Kendle and MedImmune are just a few of the industry leaders using careers. every day to find professionals like you. Check back often for new job postings!
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Lee Gellins
Fortune Personnel of Hilton Head
843-842-7221
Lee@
MANUFACTURING ENGINEERING MANAGER
Job Summary: Develops and manages engineering resources and efforts for new production programs company and its subsidiaries from the development and prototype stages through to final production stage. Provides technical supports to current production programs. This includes Planning/Business Award, Design, Prototype, Validation, Production Launch and Continuous Improvement.
Supervises: Engineering Teams, Tooling, and Maintenance
Job Duties and Responsibilities:
• Manage the direct responsibility for all engineering efforts for the personnel who report to the position.
• Direct responsibility for all Program Management activity and process improvement.
• Systems implementation, skill enhancement and standardization of policies and practices across the engineering group.
• Continuous management oversight on products in the development stage.
• Support design of new products and makes revisions as necessary.
• Communicates both internally and externally to ensure that projects are running per specifications in terms of cost, quality, and timeliness.
• Maintain close customer contact to resolve any production problems.
• Interfaces strongly with manufacturing to support existing product lines.
• Support the efforts to generates product quotations develop test methods and procedures as needed. Visits customers and vendors as required.
• Performs necessary functions to adhere to ISO13485, MDD, and FDA standards.
Qualifications:
• 5-7 years of Medical device industry experience required
• BS in Mechanical Engineering is required with added disciplines in business management a plus.
• 3-5 years of experience in managing medical device industry engineering resources with systems design required.
• Working knowledge of silicon injection molding and extrusion processes required.
• Solid project management skills. PMP certification preferred.
• Previous experience in product design, program management and launching products successfully.
• Computer literate with knowledge of spreadsheet and word processing packages, and Microsoft Project desirable.
This person should not only have the technical expertise required, but also the experience leading , training, and mentoring inexperienced engineering teams. Should be a working manager, very involved and “hands on” and has taken products from inception through manufacturing.
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CONTACT
The hiring company has engaged Jack Farrell & Associates () to find the winning candidate for this position. Interested candidates should provide a resume by email to joan@.
Senior Peer-Review Manager – Bridgewater, NJ
Our client, a strategic medical communications agency located in Bridgewater, NJ, serves global clients in the pharmaceutical and biotech industries. The agency educates the global healthcare community and enables them to make well-informed decisions regarding treatment options.
We require a SENIOR PEER REVIEW MANAGER to communicate reviewer's comments to authors and to evaluate revised manuscripts for acceptance or further revision for peer-reviewed medical journal portfolios.
RESPONSIBILITIES
Manage peer-review process
• Compile, edit and format the reviewers' comments from Editor-in-Chief and reviewers and communicate recommended changes to the authors in a professional and scientific manner.
• Evaluate the reviewers' comments for appropriateness, and completeness.
• Address any concern that the authors may have about the peer-review comments/process
Evaluate manuscript revisions
• Evaluate the author's responses to reviewers in the revised manuscript.
• Review revisions made by authors to ensure that they meet the reviewers' requirements for acceptance, and communicate further revisions if needed.
• Work closely with editors to ensure that the revised manuscript meets their requirements.
Personnel management
• Manage and collaborate with the Peer-Review Managers to facilitate the peer-review process.
REQUIREMENTS
Pharm D degree or an advanced degree in a biomedical field with 5 years relevant scientific experience.
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Contact
Alex Showers
Liberty Personnel Services
610-941-6300 ext 114
alex@
Please send a Word copy of your CV to alex@ for consideration.
Medical Writer, Medical Communications - NYC
My client, an excellent Medical Communications company in New York City is actively seeking an experienced medical writer for a full-time, permanent opportunity (On Site). Experienced writers with Medical Education or Medical Communications writing experience desired.
Requirements
In-house work; this position does not allow for remote work or telecommuting.
Qualified applicants must have the following:
• A PhD, MD, or Pharm D degree in a life sciences discipline is required
• 2+ years or more of industry experience preparing & writing (manuscripts, posters, educational programs, journal articles, executive summaries, abstracts, power point, slide kits, review articles, etc)
• Oncology, diabetes, CNS, urology, cardiovascular, gastro, therapeutic experience desired (any or all or related areas)
• Experience in a variety of therapeutic areas a plus
Keywords
Sr Medical Writer, Medical Writer, Medical Director, Scientific Director, Oncology, Project Director, Medical Education, Medical Advertising, CNS, Oncology, Journal Articles, Poster presentations, Slide kits, CD-ROMs, KOL's, Abstracts, Manuscripts, Power Point
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Contact
Anita Zalewski
PSE Co.
215.456.9055 phone
215.565.2727 fax
anita@pse-
pse-
Contract Medical Communications Scientist Philadelphia, PA
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA briefing documents).
Location: Philadelphia region
Hours: Mon - Fri; 8:30am - 4:45pm
Contract term: 12/22/10 (with potential for extensions)
Major Responsibilities
• Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
• Critically assesses, interprets, and accurately summarizes medical data.
• Contributes to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
• Promotes and exploits global working in the preparation of clinical contributions to regulatory dossiers.
• Provides innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
• Interprets and monitors current and emerging communication issues and guidelines.
• Manages contract resources through the effective use of project management skills to ensure the delivery of quality documents.
Requirements
• Degree/College Major: Science background (eg, MS/PhD)
Number of Years Work Experience Required: 3-5 years
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Design-for-Mfg Engineer at Philips Lumiled in San Jose
The job id is 61657 and the position requires BS or MS with experience;
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See jobs at . I’ve pasted in jobs for Life Technologies which are local to Bay Area.
|Title / Description |Company |Location |Date Posted |
|Senior Manager, Manufacturing |Life Technologies |Pleasanton, CA |11/08/2009 |
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|Applied Biosystems Global Operations is looking for| | |View full description |
|a seasoned Senior Manufacturing Manager to lead its| | | |
|Pleasanton, CA... | | |Save to MyBeakerBoard |
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|Intern - Chemical Engineer |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|We have multiple Chemical Engineering Internships | | |View full description |
|available for Summer 2008. Examples of projects | | | |
|include: - System ... | | |Save to MyBeakerBoard |
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|Staff Engineer, Informatics |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|Join the RD Analysis team working on the SOLiD next| | |View full description |
|generation sequencing platform. There are three | | | |
|main areas of resp... | | |Save to MyBeakerBoard |
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|Intern - Chemistry Major |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|We have multiple internships available for students| | |View full description |
|pursuing degrees in chemistry. These positions | | | |
|support various bus... | | |Save to MyBeakerBoard |
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|Intern - Biology Major |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|We have multiple internships available for students| | |View full description |
|pursuing degrees in various aspects of biology. | | | |
|These positions su... | | |Save to MyBeakerBoard |
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|Intern - Mechanical/Bio Eng Major |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|We have multiple Mechanial/Bio Engineering | | |View full description |
|Internships available for Summer 2008. Examples of | | | |
|projects include: - Sy... | | |Save to MyBeakerBoard |
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|Intern - Computer Science Major |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|We have multiple internships available for students| | |View full description |
|pursuing degrees in computer science. Examples of | | | |
|previous projec... | | |Save to MyBeakerBoard |
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|Intern - Software Technology |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|To design software algorithm infrastructure for | | |View full description |
|quantitative reverse transcriptase polymerase chain| | | |
|reaction (RT-PCR) ... | | |Save to MyBeakerBoard |
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|Sr. Staff Scientist, Bioinformatics - Next |Life Technologies |Foster City, CA |11/08/2009 |
|Generation Sequencing | |USA | |
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|SR STAFF SCIENTIST BIOINFORMATICS RESPONSIBILITIES | | | |
|We are seeking a talented | | |Save to MyBeakerBoard |
|bioinformatician/computational biolo... | | | |
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|Technician 2, Service |Life Technologies |Pleasanton, CA |11/08/2009 |
| | |USA | |
|The Service Technician will perform maintenance, | | |View full description |
|testing, troubleshooting, calibration and repair on| | | |
|a variety of Manu... | | |Save to MyBeakerBoard |
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|Title / Description |Company |Location |Date Posted |
|Associate Product Manager, Genetic Analysis |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|PRODUCT MANAGER GENETIC ANALYSIS CONSUMABLES | | |View full description |
|OVERVIEW We are seeking an Associate Product | | | |
|Manager for the Genetic ... | | |Save to MyBeakerBoard |
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|Mass Spec- Field Applications Support- Applied |Life Technologies |Various, NJ USA |11/08/2009 |
|Markets | | | |
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|The Senior Field Applications Specialist is | | | |
|responsible for providing high-level pre-sales and | | |Save to MyBeakerBoard |
|post-sales support for ... | | | |
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|Sr Staff Engineer, Algorithms |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|SR STAFF ENGINEER, ALGORITHMS Design, develop, | | |View full description |
|implement and maintain data analysis components, | | | |
|systems and software ... | | |Save to MyBeakerBoard |
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|Staff Engineer, Mechanical |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|Major responsibilities include design and | | |View full description |
|implementation of of manufacturing systems for | | | |
|consumable products, and mana... | | |Save to MyBeakerBoard |
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|Product Applications Specialist 3 - PCR Solutions |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|SPECIALIST 3, PRODUCT APPLICATIONS RESPONSIBILITIES| | |View full description |
|Drives PCR applications on End-pt PCR and Real-Time| | | |
|PC... | | |Save to MyBeakerBoard |
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|Senior SAP Basis Administrator |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|We are currently seeking a Senior level SAP Basis | | |View full description |
|Administrator for our Foster City office in | | | |
|California. In this po... | | |Save to MyBeakerBoard |
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|Chemical Process Technician |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|Filling of liquids and powders as well as finished | | |View full description |
|goods in a manner consistant with good laboratory | | | |
|proctices, compli... | | |Save to MyBeakerBoard |
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|Senior Scientist, Bioinformatics |Life Technologies |Foster City, CA |11/08/2009 |
| | |USA | |
|SR SCIENTIST BIOINFORMATICS RESPONSIBILITIES We are| | |View full description |
|seeking a talented bioinformatician/computational | | | |
|biologist to ... | | |Save to MyBeakerBoard |
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|Title / Description |Company |Location |Date Posted |
|Senior Scientist Product Development |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|Major Responsibilities: We are currently | | |View full description |
|seeking a skilled and highly-motivated | | | |
|Scientist for a Development and Pilo... | | |Save to MyBeakerBoard |
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|Royalty Administrator |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|The Royalty Administrator position is | | |View full description |
|responsible for supporting the Manager of | | | |
|Licensing Royalty Compliance and the ... | | |Save to MyBeakerBoard |
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|Product Manager Taqman MicroRNA Assays |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|PRODUCT MANAGER TAQMAN MICRORNA BACKGROUND | | |View full description |
|For over 25 years Applied Biosystems has | | | |
|brought leading edge scientifi... | | |Save to MyBeakerBoard |
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|Senior Solution Architect |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|The Senior Solution Architect provides | | |View full description |
|technical and business domain expertise in | | | |
|support of Professional Services. In... | | |Save to MyBeakerBoard |
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|Product Applications Specialist 3 |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|RESPONSIBILITIES The Role of Bioinformatics | | |View full description |
|Applications Specialist is to support the | | | |
|Next Generation Sequencing SOLi... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Maintenance Technician |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|This position will have a critical role in | | |View full description |
|troubleshooting, diagnosis and repair of | | | |
|consumables manufacturing equipmen... | | |Save to MyBeakerBoard |
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|Product Applications Sr. Specialist - Taqman|Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
| | | |View full description |
|PRODUCT APPLICATIONS SPECIALIST TAQMAN | | | |
|PROTEIN EXPRESSION ASSAYS OVERVIEW As the | | |Save to MyBeakerBoard |
|leading supplier of life science ... | | | |
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|Staff Engineer, Chemical Process |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|Major Responsibilities: Develops, | | |View full description |
|implements, and qualifies robust, | | | |
|cost-effective processes for manufacturing | | |Save to MyBeakerBoard |
|leadin... | | | |
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|Global Commodities, Procurement Specialist |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|The Sr Buyer/Planner will identify sources | | |View full description |
|of supply, negotiate contracts and implement| | | |
|supplier agreements for plasti... | | |Save to MyBeakerBoard |
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|Title / Description |Company |Location |Date Posted |
|Senior Database Administrator-SQL Server |Life Technologies |Foster City, CA USA |11/08/2009 |
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|Position Location: Rockville, MD SQL Server | | |View full description |
|Database Administrator will work as part of a| | | |
|DBA team that provides 24x7... | | |Save to MyBeakerBoard |
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|Development Scientist |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|Major Responsibilities: We are currently | | |View full description |
|seeking a high-motivated individual to join | | | |
|the Product Development group of... | | |Save to MyBeakerBoard |
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|Inspector 2, Quality Compliance |Life Technologies |Bedford, MA USA |11/08/2009 |
| | | | |
|Successful performance of job duties | | |View full description |
|contributes to meeting production schedules, | | | |
|customer satisfaction, departmental ... | | |Save to MyBeakerBoard |
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|Senior SAP Configuration Lead |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|Senior SAP Configurator ( Manufacturing and | | |View full description |
|Production Planning) We seek a strong SAP | | | |
|Product Planning and Manufact... | | |Save to MyBeakerBoard |
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|Senior SAP Configuration Lead |Life Technologies |Foster City, CA USA |11/08/2009 |
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|Senior SAP Configurator ( Finance FI module) | | |View full description |
|We seek a strong SAP Finance Module expert | | | |
|with excellent configurati... | | |Save to MyBeakerBoard |
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|Sr Analyst, Business Process |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|Major Responsibilities: Participate in the | | |View full description |
|identification, evaluation, and | | | |
|implementation of SAP related security too...| | |Save to MyBeakerBoard |
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|Senior Manager - Facility/Maintenance |Life Technologies |Foster City, CA USA |11/08/2009 |
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|BASIC FUNCTION AND SCOPE OF THE POSITION: | | |View full description |
|Provide technical leadership, mentoring and | | | |
|supervision to the maintenance... | | |Save to MyBeakerBoard |
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|Sr. Analyst, Programmer -SAP BW |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|We are seeking a SAP BW Developer to | | |View full description |
|maintain, monitor and develop the company's | | | |
|SAP BW implementation. This role wil... | | |Save to MyBeakerBoard |
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|Cold Fusion Developer |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|We have a great career opportunity for an | | |View full description |
|experienced Cold Fusion Developer. You will | | | |
|Collaborate with Business Analy... | | |Save to MyBeakerBoard |
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|Title / Description |Company |Location |Date Posted |
|Field Service Engineer |Life Technologies |Various, CA USA |11/08/2009 |
| | | | |
|Primary Role The Field Service | | |View full description |
|Engineer is responsible for | | | |
|ensuring a high rate of customer | | |Save to MyBeakerBoard |
|satisfaction through the... | | | |
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|Sales Specialist SOLiD Next |Life Technologies |Various, MA USA |11/08/2009 |
|Generation Sequencing- Boston | | | |
| | | |View full description |
|SALES SPECIALIST SOLiD NEXT | | | |
|GENERATION SEQUENCING | | |Save to MyBeakerBoard |
|RESPONSIBILITIES As a member of | | | |
|our dynamic, high achieving | | |Email to a friend |
|sale... | | | |
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|Sr Technical Trainer - DNA |Life Technologies |Foster City, CA USA |11/08/2009 |
|Analysis | | | |
| | | |View full description |
|Major Responsibilities Work | | | |
|within the Technical Training | | |Save to MyBeakerBoard |
|Department to train employees on | | | |
|AB applications. This incl... | | |Email to a friend |
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|Sr Specialist, Technical Training|Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
| | | |View full description |
|Major Responsibilities Work | | | |
|within the Technical Training | | |Save to MyBeakerBoard |
|Department to train AB field | | | |
|service engineers and other em...| | |Email to a friend |
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|Field Application Specialist - |Life Technologies |Seattle, WA USA |11/08/2009 |
|Houston or Seattle/Denver | | | |
| | | |View full description |
|Major Responsibilities: Requires | | | |
|3-5 years of previous laboratory | | |Save to MyBeakerBoard |
|experience to include expertise | | | |
|in basic techniques... | | |Email to a friend |
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|Product Manager, Sequencing |Life Technologies |Foster City, CA USA |11/08/2009 |
|Analysis Software | | | |
| | | |View full description |
|RESPONSIBILITIES Responsible for | | | |
|managing the Sequencing Analysis | | |Save to MyBeakerBoard |
|software product family, | | | |
|including developing the... | | |Email to a friend |
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|Sales Rep Molecular Biology - |Life Technologies |Foster City, CA USA |11/08/2009 |
|Boston | | | |
| | | |View full description |
|Major Responsibilities Exceed | | | |
|plan for product responsibility -| | |Save to MyBeakerBoard |
|Provide sales expertise with | | | |
|regard to market, AB app... | | |Email to a friend |
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|Sales Rep Genetic Systems - |Life Technologies |Foster City, CA USA |11/08/2009 |
|MA/NH/ME | | | |
| | | |View full description |
|Major Responsibilities - Exceed | | | |
|plan for product responsibility -| | |Save to MyBeakerBoard |
|Provide sales expertise with | | | |
|regard to market, AB a... | | |Email to a friend |
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|Web Administrator |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|*Note* This is NOT a WEB | | |View full description |
|DEVELOPER position This | | | |
|position is responsible for | | |Save to MyBeakerBoard |
|the deployment and | | | |
|maintenance of g... | | |Email to a friend |
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|Product Manager PCR |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|PRODUCT MANAGER CONSUMABLES | | |View full description |
|RESPONSIBILITIES Developing | | | |
|the long-term product | | |Save to MyBeakerBoard |
|direction and managing all | | | |
|customer ... | | |Email to a friend |
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|Title / Description |Company |Location |Date Posted |
|Technical Application Scientist |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|TECHNICAL APPLICATIONS SPECIALIST | | |View full description |
|RESPONSIBILITIES: The hybrid | | | |
|Technical Applications Scientist (70%| | |Save to MyBeakerBoard |
|field/30% rem... | | | |
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|Call Center Coordinator, 2 |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|Major Responsibilities Provides phone| | |View full description |
|support activities for the Field | | | |
|Service Support Groups. Requires | | |Save to MyBeakerBoard |
|knowledge... | | | |
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|Sales Rep Genetic Analysis AL/MS/FL |Life Technologies |Various, FL USA |11/08/2009 |
| | | | |
|RESPONSIBILITIES - Exceed plan for | | |View full description |
|product responsibility - Provide | | | |
|sales expertise with regard to | | |Save to MyBeakerBoard |
|market, AB applica... | | | |
| | | |Email to a friend |
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|Sr InstallSheild and Build Engineer |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|Major Responsibilities:Seeking a | | |View full description |
|senior InstallSheild and Build | | | |
|Engineer to develop installers for | | |Save to MyBeakerBoard |
|our commercial soft... | | | |
| | | |Email to a friend |
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|Product Manager, Public Health |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|Responsible for products delivered to| | |View full description |
|Public Health customers, including | | | |
|developing long term strategy, | | |Save to MyBeakerBoard |
|defining produ... | | | |
| | | |Email to a friend |
| | | | |
|Web Administrator |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|*Note* This is NOT a WEB DEVELOPER| | |View full description |
|position This position is | | | |
|responsible for the deployment and| | |Save to MyBeakerBoard |
|maintenance of g... | | | |
| | | |Email to a friend |
| | | | |
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|Product Manager PCR |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|PRODUCT MANAGER CONSUMABLES | | |View full description |
|RESPONSIBILITIES Developing the | | | |
|long-term product direction and | | |Save to MyBeakerBoard |
|managing all customer ... | | | |
| | | |Email to a friend |
| | | | |
|Sr Scientist |Life Technologies |Foster City, CA USA |11/08/2009 |
| | | | |
|Applied Markets division of Applied | | |View full description |
|Biosystems produces assays to perform| | | |
|human identification for crime scene | | |Save to MyBeakerBoard |
|investi... | | | |
| | | |Email to a friend |
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|Supplier Quality Engineer |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|Job Summary: As a key member of the Supplier | | |View full description |
|Quality Organization, you will manage | | | |
|supplier quality issues, supplier a... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|SAP Finance Business Analyst |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|The role of the Senior Finance Business | | |View full description |
|Systems Analyst involves project management, | | | |
|solution design development as w... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Facilities Maintenance Mechanic |Life Technologies |Foster City, CA|11/08/2009 |
| | |USA | |
|- Perform preventive maintenance (PM) and | | |View full description |
|repairs on facilities equipment. - Provide | | | |
|support to the Site Services Team... | | |Save to MyBeakerBoard |
| | | | |
| | | |Email to a friend |
| | | | |
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|Sales Specialist SOLiD Next Generation |Life Technologies |Various, CA USA|11/08/2009 |
|Sequenciing- Bay Area | | | |
| | | |View full description |
|SALES SPECIALIST SOLiD NEXT GENERATION | | | |
|SEQUENCING RESPONSIBILITIES As a member of | | |Save to MyBeakerBoard |
|our dynamic, high achieving sales... | | | |
| | | |Email to a friend |
| | | | |
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Jobs That Crossed My Desk Through Nov. 1, 2009
********************************************************************************************
Christopher Corey
> Executive Recruiter
> Search Group of San Diego
> 858-217-5582
> chris@sgsd.jobs
>
Principal Scientist, Pharmaceutical Sciences
Formulation Development
The Principal Scientist will plan, direct, and execute formulation & manufacturing process development activities in support of development of new products intended for clinical trials and commercialization with focus on controlled-release ocular implants. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.
The essential components of this position are in-depth understanding of pharmaceutical formulation principles, global CMC regulatory requirements as well as strong organizational skills to develop formulations intended for clinical trials and commercialization. Specifically,
◦Provide scientific and technical leadership for pharmaceutical product development projects and in general, Global Pharmaceutical Sciences.
◦Demonstrate scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
◦Represent department at project team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
◦Apply current CMC regulatory requirements and guidances to support global registration of new products.
◦Exhibit leadership skills that result in good performance and career development of junior staff.
◦Have excellent oral and written communication skills.
Qualifications
This position requires a Ph.D.-level education preferably in pharmaceutical sciences or chemical engineering with eight years of applicable experience with emerging national recognition, which is defined as having accomplished three or more of the following:
◦scientific findings that have the potential to open new markets and market opportunities and will add to the company's technology base
◦patents in the area of specialization
◦scientific publications in areas of specialization
◦has been an invited speaker at national meetings or short courses
◦has been a reviewer for manuscripts submitted for publication
Must be able to function as a CMC team leader and utilize knowledge of pharmaceutical science, chemical engineering, literature and experience to guide decisions in complex situations. Knowledge of fundamental applications of statistics is preferred.
(Job Number: 090445)
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Contact: John Colantoni/JWC Associates
Phones: 732-792-2933 and 609-921-9090
E-mail: jwchh500@
STAFF ENGINEER-MECHANICAL ENGINEERING, Central NJ
- Function as a Subject Matter Expert in mechanical systems used in Bio Pharmaceuticals, with an extensive knowledge of HVAC, Utility and Compendia Water Systems.
- Provide technical leadership on standards for engineering and engineering related topics, across the organization Provide strategic guidance and expert technical support for capital investments and for ongoing operations.
MAJOR DUTIES
- Responsible to make Engineering more effective and efficient by translating technical knowledge and lessons learned into meaningful direction to the engineering community across the organization.
- Serve as an expert knowledge resource to the internal customers.
- Accountable for the technical content and timely delivery of all discipline related standards and directives and to harmonize standards for technical solutions, equipment & CQV CSV across various groups.
- Provide project specific technical support all stages of capital projects.
- Accountable to ensure that the design meets its intent and it complies with the Design Standards.
EXPERIENCE DESIRED
- Understands and embraces concept of Engineering as knowledge based service.
- Experience with facility types core to the business, such as Bulk Chemical & Biologics API, OSD, Aseptic processes in commercial manufacturing, clinical supply and R&D environment.
- Strong knowledge of fundamental design principles for cGMP compliance in Pharmaceutical Operations and supporting systems.
- Demonstrated understanding of business needs, risks, applicable codes and regulatory implications of the technical choices.
- Strong understanding of the role of engineering in the execution of projects with demonstrated ability to maintain active participation.
- Ability to lead people in multi disciplinary engineering teams Proven ability to communicate clearly and directly at all levels, with both integrity and discretion.
- Partner with Stakeholders to balance business objectives with scope, cost, and schedule requirements.
- Effectively utilizes relationships with internal and external stakeholders to leverage best practices and achieve project objectives.
OTHER
- BS in Engineering with 7+ years experience in bio pharmaceuticals or related industry is required. MS in Engineering, PE preferred Individual contributor. ME preferred
- 25 percent Travel with overnight stays.
Salary in the six-figures, bonus, and relocation. Position is based in New Jersey
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uses the internet to conduct trade shows for the pharma and life science industries. Besides providing exhibits of various services and products, also has a click-by-state job bulletin (job) for employers/recruiters and job-seekers to post and find pharma jobs, biotech jobs, and other life science jobs for free. The following is a list of recent job postings:
JD Edwards CSV Consultants
Senior Pathlogist with MedImmune MD
Scientist with MedImmune MD
Senior Account Manager San Francisco
Medical Director San Francisco
Pls go to our job bulletin job . It’s easy to use the View All Jobs function to find jobs. Pls read the job descriptions carefully. Pls check that there is a reasonable fit and then follow the specified instructions to apply. Pls be sure to mention that you found the job(s) at .
is also launching its one-of-a-kind science eCards. Pls be free to check them out. Pls also join us at our new linkedin group “Pharma & Life Science Mixer”. We wish you all lots of successes.
*******************************************************************************************
Here is a position for a Senior Regulatory Affairs Associate in Colorado.
If you are interested, contact
Melissa Morof
Clinical Research Recruiter
Kelly Scientific Resources
Telephone: 248-244-5499
Toll Free: 877-269-5401
Fax: 248-244-4172
E-mail: MOROFME@
clinical
Position Description:
Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. KSR is the first and largest scientific staffing company in the world, and we currently have an exciting direct hire full-time Senior Regulatory Affairs Associate position available in the Fort Collins, Colorado area.
Purpose and Scope
Under minimal supervision, perform all functions pertaining to domestic and international regulatory submissions including review of documentation, preparation of documents for electronic or paper filing, compilation of submissions, and review/approval of final submissions.
Essential Duties & Responsibilities
• Serve as regulatory representative on project teams. Offer regulatory opinions with consultation from senior regulatory management.
• Coordinate with personnel from other departments to obtain data/documentation for submissions and maintain timelines.
• With supervision from Regulatory Manager, act as liaison with regulatory agencies.
• Review draft investigational and commercial labeling artwork.
• Assist Regulatory Manager as requested.
• Perform regulatory research tasks as requested.
• Assist in or maintain product applications (INDs, NDAs, ANDAs).
• Maintain electronic document management system as required.
• Conform to regulatory department standards.
• Prepare and assist in preparation of domestic and international regulatory submissions.
• Provide training and guidance to other staff members when needed.
• Provide review of informed consents and protocols.
• Maintain up-to-date knowledge of current guidance and regulations.
• Perform various other duties as assigned.
Knowledge, Skills & Abilities
• Demonstrated knowledge of MS Office, Adobe Framemaker and Adobe Reader/Writer.
• Excellent writing and organizational skills.
• Ability to work independently.
• Ability to coordinate information from various internal and external disciplines.
• Ability to understand regulatory and technical concepts and requirements.
• Ability to perform multiple tasks on several projects.
• Ability to prepare written summaries of technical data suitable for inclusion in regulatory submissions.
• Ability to understand, and comply with domestic and international regulatory requirements.
• Ability to follow specific directions and to request instructions for complex tasks.
Education & Experience
• Bachelor's degree in related field.
• Four or more years experience in the pharmaceutical/biologic industry with knowledge of preparing and submitting regulatory dossiers/applications to regulatory agencies.
Benefits & Compensation
• 65 – 85 K per year plus benefits
• Competitive health care package
• GREAT vacation and paid time off
• Relocation assistance provided
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. We provide clinical research and scientific staffing to pharmaceutical, biotechnology, medical device and contract research organizations across the US. Kelly Services is an Equal Opportunity Employer.
To be immediately considered for this position, please e-mail morofme@ or call 1-877-269-5401!
*****************************************************************************************************************************
Jobs listed for Prometheus Labs in San Diego. Go to
|Title / Description |Company |Location |Date Posted |
|Technical Sales Specialist |Prometheus Laboratories |, US |10/30/2009 |
| | | | |
|For further information about our current Technical| | |View full description |
|Sales Specialist openings, click on "Apply Now" and| | | |
|you will be dire... | | |Save to MyBeakerBoard |
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|Sr. Technical Operations Scientist II |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
| | | | |
|SUMMARY Responsible for developing and | | |View full description |
|troubleshooting assays and procedures to transfer | | | |
|to Lab Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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|Sr. Technical Operations Associate II |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
| | | | |
|SUMMARY Assists with the transfer of new and | | |View full description |
|existing assays from Research & Development to Lab | | | |
|Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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| | | |Email to a friend |
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|Sr. Technical Operations Associate II |Prometheus Laboratories |San Diego, CA US |10/30/2009 |
| | | | |
|SUMMARY Assists with the transfer of new and | | |View full description |
|existing assays from Research & Development to Lab | | | |
|Operations. ESSENTIAL DU... | | |Save to MyBeakerBoard |
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Contact:
All inquiries should come to Carol Howard, Sr. Recruiter, Assent Consulting. (408) 540-4915 or carol@ 10054 Pasadena Avenue, Cupertino, CA 95014, .
Clinical Study Report Project Manager
San Francisco Bay Area
6-month, full-time on-site contract in San Francisco
SUMMARY:
Coordinate the various aspects of preparing the Clinical Study Report (CSR) for regulatory submission in a timely manner
DUTIES & RESPONSIBILITIES:
* Coordinate the outsourced components of the study report
* Diplomatically manage the production deadlines of the report generation team
* Manage versions, editing, and timelines
REQUIREMENTS:
* Familiar with all aspects of the CSR
* Medical writing and CSR generation expert
* Strong project management background
* Four-year degree
_______________________________________________________________________
Clinical Document Quality Check Contractor
San Francisco Bay Area
This position is a 6-month, full-time, on-site contract.
The contractor will be responsible for reviewing up to 25 data tables per day, as well as reviewing/editing Clinical Study Reports.
Candidates should have knowledge of data tables, CSRs, and Regulatory Documents. Candidates must be on-site in Mountain View, CA, location.
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Contact:
Interested candidates may apply online at .
Clinical Content Specialist (Drug Information)
Greenwood Village, CO
Title: Clinical Content Specialist (Drug Information)-PUB00002158
Job: Publishing/Editorial
Primary Location: US-CO-Greenwood Village
Organization: Healthcare US
Schedule: Full time
Education Level: Bachelor's Degree (±16 years)
Job Type: Standard
Shift: Day Job
Employee Status: Regular
Description:
The healthcare business of Thomson Reuters provides insights -- information, benchmarks, and analysis--that enable organizations to manage costs, improve performance, and enhance the quality of healthcare. The Clinical Content Specialist is responsible for content creation, review, and maintenance, utilizing multiple complex sources of information and editorial technology.
• Applies critical literature evaluation skills, knowledge of pharmacokinetics, pharmacodynamics, disease state and therapeutic endpoints to accurately assess efficacy and/or comparative efficacy of drug therapy
• Identifies, evaluates and utilizes appropriate references/literature to determine, support or reject an appropriate drug dose based on patient-specific parameters and based on definitive criteria and/or outcomes
• Utilizes substance-specific pharmacokinetic and pharmacodynamic knowledge to identify or predict a potential mechanism for a drug interaction, adverse effect, therapeutic effect or toxic effect
• Synthesizes complex information from multiple, sometimes conflicting, sources to form a conclusion
• Researches and resolves editorial inquiries requiring domain expertise
• Performs quality control testing of Healthcare products; assists with development of quality assurance protocols
• Applies critical literature evaluation skills to develop and implement editorial policies and style guidelines
• Keeps up-to-date on current practices within specialty content area(s); maintains awareness of current controversies, issues and developments
• May provide support to other departments and business units as required
• Reviews written content and provides feedback to writers to improve quality of content
Qualifications:
• Demonstrated ability to apply clinical knowledge and experience in critical thinking and problem-solving; ability to recognize discrepancies in data and interpret and draw inferences from complex data
• Ability to solve problems, independently organize work and perform multiple tasks
• Demonstrated ability to communicate with management and other team members
• Demonstrated expertise in critical literature evaluation skills
• Solid knowledge of Internet search engines and strategies
• Demonstrated writing ability and knowledge of grammar, punctuation and sentence structure; computer literacy; knowledge of word processing and relational database applications
• BS Degree in Pharmacy plus 2 years related clinical experience or PharmD (residency preferred). Active pharmacy license required(may be held in any of the 50 states)
Thomson Reuters employees take pride in providing our customers around the world with information that is timely, accurate, unbiased and trusted. We have a profound respect for the professions and customers we serve and define our success in terms of their success. Our work environment is dynamic, innovative and entrepreneurial. We have a result-oriented culture that demands excellence, agility, and the desire to move quickly and precisely to seize opportunities. Our environment is both challenging and supportive - we give employees the opportunity to develop their skills and do their best work.
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Please contact me if you know of anyone who could be a good fit.
Julie
Managing Director
JGB BioPharma Consulting
650-520-3433
I am working for 2 local bay area clients that would like to fill full time positions (Clinical Research Associate/CRA to Senior CRA). One is in-house based (so little travel and no direct monitoring) and the second includes both in-house work and monitoring (some USA travel).
****************************************************************************************************************************
Contact:
Matt Soloperto
Search Consultant
Clockwork Consulting, LLC
162 Sidney Street
Cambridge, MA 02139
ph: 617.225.0397
fax: 617.225.0308
msoloperto@
Senior Manager/Associate Director, Medical Writing – Cambridge, MA
Type of Job: Direct hire; permanent role
Compensation: Will discuss with each interested party
General Description:
Management of several writers comprising a subdivision of the Medical Writing Department. Reports to Director of Medical Writing. Writes documents associated with clinical trials. Forecasts and fills resource needs for projects under his/her supervision.
Detailed Description and Job Scope:
Supervises Writers and Editors. Reviews work of Medical Writers and/or Editors and assists in their professional development. Models rigorous and disciplined approaches to medical writing. Communicates a philosophy which strikes a proper balance between high production and high quality. Helps writers to utilize their strengths and work around their weaknesses.
Responsible for resource planning and allocation. This includes forecasting of medical writing needs through analysis of clinical development plans, and monitoring of changes in those plans. Identifies time periods when resources will be taxed and makes plans accordingly. Outsources work regularly to ensure that in-house resources are always available for work that can only be done in-house.
Regularly reviews Department's operations and seeks to improve its effectiveness and efficiency. Develops solutions and oversees their application or directs others to this end. Participates in initiatives which seek to improve our processes. Carries out novel or complex assignments.
Plays an important role in cross-functional teams. Must be highly skilled in representing Medical Writing group in the interdepartmental planning of clinical projects, including regulatory submissions. Demonstrates exceptional ability to collaborate.
Responsible for management of medical writing resources for several development projects. Establishes and enforces timelines for multiple projects and writers. Plays a key role in negotiating timelines for primary projects throughout the organization. For projects under the Senior Manager's supervision, responsible for planning and provision of medical writing resources for submission of marketing applications. Collaborates with other departments to construct timelines and guidelines for the review of summary documents.
Reports to Director of Medical Writing and regularly informs him of the status of projects, morale and performance of direct reports, resource gaps which need to be filled, the quality and timeliness of outsourced work, status of collaboration with other departments, and any other issues which need to be addressed. Assists Director in long-term planning.
Qualifications for Job (Knowledge, Skills, Abilities, Effectiveness, Collaboration and Leadership):
Management skills. Actively increases team performance by aligning objectives, promoting a team approach, and addressing concerns or discord. Considers multiple perspectives and helps team members optimize results. Mentors Medical Writers and Editors.
Must show a broad understanding of clinical research processes, and a familiarity with regulatory processes, along with an in-depth knowledge of other clinical functional areas. Strong understanding of other clinical functions is needed to recognize and appreciate how other departments interact with, and are dependent on, Medical Writing.
Demonstrated expertise in clinical research documentation, ICH guidelines, FDA guidances, and GCP. An understanding of company SOPs, including the need for revision. Will serve as a technical expert in processes for the clinical research team. Well-developed communication and negotiation skills in team environments required.
Must have an in-depth expertise in clinical research and medical writing in particular. Acts as an authoritative resource on medical writing and other areas in clinical research. Ability to influence project strategy and document construction. Demonstrated ability to analyze and resolve complex problems.
Proficient in using Microsoft Excel, Project, and PowerPoint.
Requirements for Job (Years of Experience, Education, Certifications):
MS/MPH in Medical or Life Sciences plus 5 years' experience (or equivalent), including medical writing, project management, and/or clinical monitoring, plus at least one year of proven managerial reponsibility supervising writers.
********************************************************************************************************************
Contact:
Anita Zalewski
PSE Co.
215.456.9055 phone
215.565.2727 fax
anita@pse-
pse-
Contract Medical Communications Scientist Philadephia, PA area
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents).
Location: Philadelphia region
Hours: Mon - Fri; 8:30 am - 4:45 pm
Contract term: 12/22/10 (with potential for extensions)
Major Responsibilities:
• Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
• Critically assesses, interprets, and accurately summarizes medical data.
• Contributes to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
• Promotes and exploits global working in the preparation of clinical contributions to regulatory dossiers.
• Provides innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
• Interprets and monitors current and emerging communication issues and guidelines.
• Manages contract resources through the effective use of project management skills to ensure the delivery of quality documents.
Requirements: Degree/College Major:
• Science background (eg, MS/PhD)
• Years Work Experience Required: 3-5 years
Minimum Requirements:
• Baccalaureate degree in biomedical discipline.
• Knowledge of the drug development process and human pathophysiology and diseases.
• Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly.
• Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management.
• Knowledge of regulatory requirements and guidelines and standards.
• Ability to travel nationally and internationally
Preferred Background:
• Advanced biomedical degree.
• Budget and resource management skills.
• Editor in Life Sciences (ELS) certification.
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Other Information for Those in Transition
*************************************************************************************************
Upcoming Bioscience Business and Marketing Courses in the fall at UCSC Extension at the new location in Santa Clara near intersection of 101 and Bowers…please help us promote these courses beyond those who have taken them already. There’s little information about these courses developed specifically for working professionals in the life science industry. These two days of intensive classroom work followed by 2 months of work done at student’s home location allows for participants who come from outside the Bay Area on business and add on two days and take a top rated course from experts in the field at an affordable price.
December 3-4, BIOSCIENCE BUSINESS DEVELOPMENT: BUILDING VALUE
UCSC Extension in Silicon Valley presents a two-day intensive course that brings the breadth of the Bay Area’s biobusiness development expertise to our Cupertino classroom. Whether financing start-up activities, trying to keep pace with the current burn rate, or moving a product into the marketplace, bioscience companies, both large and small, have a critical need for business development at every stage of their evolution. Learn the key roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Santa Clara, CA. For more information, see ucsc-extension.edu/biobizdev
***********************************************************************************************
Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.”
The link; .
*********************************************************************************************
Job Sites
The most known site for career and job listings is which focuses on biotech and pharma.
A newer website which includes jobs but also a virtual exhibit hall for companies—this one is dedicated to pharma entitled at
There’s another site which is focused on life science recruitment and placement; note featured company listings each week—
There’s website with jobs specific to medical device area at the .
Another new site with listings of interns, consultants and some jobs is
I’ve just received information on another new site with sole focus on medical devices and most in the Bay Area is I’m told they had 97 placements last year. Check this one out and let me know if you have good results.
You can look up pharmaceutical jobs in your area by zip code at . They include all functions in pharmaceutical companies.
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Other Helps
I received Biotech Ink Insider from Susan Caldwell, a local medical writer. She always has great insights as well as jobs at times to share. I’ve pasted in some videos mentioned by Susan that might be of interest for your job search:
Writing a Resume: When seeking a job, the resume is of considerable importance--it's your calling card and door opener. Here's a video that helps you create the right resume and minimizing the stress while you do it. Includes ten rules for how to approach your resume, interview, and job search. Very good basic advice.
Writing Your Resume Cover Letter: Same instructor as for Writing a Resume (above). Gives good basic advice on how to craft your cover letter and get the job interview you seek.
The Art of Medical Writing: Short video on the Masters in Medical Writing program at the University of Philadelphia, the only such training program in the world.
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Susan Caldwell wrote an article regarding writing a resume as well.
10 Tips for Creating a Door-Opening Resume
by Susan E Caldwell
If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers.
As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions:
1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database.
Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance:
Introduction or Career Goal
Summary
Work History or Professional Accomplishments (if candidate has work history)
Academic Background
Skills
Honors and Awards
Publications
There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections.
When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization.
2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position.
3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume.
4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies.
5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny.
6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice.
The remaining points in this article address issues within your resume's sections:
7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job.
8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.)
A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous.
As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history.
9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility.
10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers.
Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.
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About the Author
Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008.
You can email Susan at caldwell@, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account).
Copyright 2009 Biotech Ink, LLC. All rights reserved.
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Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing.
As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order:
1.
2.
3.
4.
5.
6.
7.
8.
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See free downloadable annual Salary Survey from Contract Pharma at
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Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, , published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at .
This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search () and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities.
The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon.
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These job postings are listed on my blog accessed at along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@ if they wish to receive these mailings directly.
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