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| 14 May 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 14 |
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Open Jobs and Gigs for Medical Writers |
 The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters.
Because of the tough job market, the Insider now lists open jobs that are closely related to medical writing, or that have a strong writing role, regardless of their titles. Examples include biostatistician, director of clinical research, and other clinical research titles.
If you receive calls about staff or contract medical writing or related positions that you aren't interested in, please forward the job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider. |
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Medical Communications Scientist, Contract Wilmington, DE | |
The Contract Medical Communications Scientist provides medical communication expertise in the production of regulatory documentation (including regulatory dossiers, Investigator Brochures, protocols, FDA Briefing documents) across product life cycle to ensure timely registration and to sustain competitive products in the US.
Contract to extend through April 2011.
Degree or college major: Science background (eg, MS or PhD) Required work experience: 3-5 years Major Responsibilities:
Prepares regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards Critically assesses, interprets, and accurately summarizes medical data 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 Qualifications:
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 -Influencing, interpersonal skills -Able to travel nationally and internationally
Preferred Background:
-Advanced biomedical degree -Budget and resource management skills -Knowledge of competitors and competitor products -Editor in Life Sciences (ELS)
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Labeling Ops Consultant Gaithersburg, MD | |
Contract length: 6+ months
Location: On site in Gaithersburg, MD; 40 hrs, 5 days per week
Current Situation:
The Labeling Operations group is looking for a Labeling Op's Contractor for a 6 month + assignment. This person will report into the Associate Mgr. of Labeling Op's. This group is a subdivision of the labeling group, but their sole focus is the operations side of labeling (implementing updates, coordinating with manufacturing, proofreading, and ensuring regulatory compliance of package labels). This position deals with the labeling of the package the drugs are sold in, not the package insert, not the label on the actual drug container inside the package. Hiring Process:
Phone screen and face to face
Required Skills:
1. Must have experience with package labeling and must have a strong background in project management and proofreading.
2. Must have a firm understanding of the finer points of EU submissions as well as US.
3. Must have experience in interfacing with Manufacturing / Production and their time lines.
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Medical Writer Plainsboro, NY |
Excellent opportunity for an experienced medical writer to work with a major pharmaceutical company.
Requirements:
Strong background in Health Economics and Outcomes Research
PhD/PharmD preferred
Experienced in writing all sections of AMCP Dossiers
Intimately familiar with AMCP Dossier Guidelines
Strong project management and time management skills
Highly skilled in the use of document templates and Microsoft Word
Familiar with the requirements of electronic publishing
Able to edit his or her work following the guidelines of the AMA Manual of Style
Committed to producing high-quality, evidence-based documents on tight timelines
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