| 3 December 2010 Published weekly by Biotech Ink, LLC | Vol 3 No 31 |
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Inside the Insider | |
Principal Medical Writer, Regeneron; Tarrytown, NY
Clinical Data Manager; Pleasanton, CA |
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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 worldwide 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. |
 Principal Medical Writer |
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer.
Regeneron offers an extremely competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits.
Job Description
The in-house Principal Medical Writer works independently writing CSRs, CSPs, IBs, and Clinical Summaries. Contributes to document strategy in a therapeutic area, and can lead the Medical Writing effort in a clinical filing. Ensures adherence to regulatory guidelines, and works with senior members of the department to help set department document standards. Helps to coordinate the efforts of the consultant writers and vendors.
Essential Duties and Responsibilities
As the Medical Writing Lead, will provide guidance to the Medical Writers and Study Team for the content, format and organization of clinical filings.
Working with the clinical team, writes the following documents: Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Investigator brochures, Clinical Summaries and other documents, as needed.
Review documents related to the CSR, such as SAP, draft TFLs, ensuring that they provide the data necessary for an appropriate CSR.
Responsible for tracking all documents in a therapeutic area.
Ensure adherence to regulatory guidelines and works with senior members of the Medical
Writing staff to help produce department guidelines, templates, standard timelines and SOP's.
Liaise with Study Director and/or Medical Monitors to shape and review content of the documents. Resolve issues and escalates problems, as necessary.
Requirements
At minimum, a Bachelor's degree (BS) from an accredited college or university, and 6 years of medical writing experience (CSR's, CSP's, IB, and Clinical Summaries).
Experience leading NDA/BLA filings and some management experience.
EMEA filing experience a plus.
Strong knowledge of the clinical research process and regulations/guidelines required.
Must have strong organizational, interpersonal, leadership, and communication skills.
Must be able to communicate effectively in large or small group settings.
Effective influence and relationship management skills required.
Working knowledge of one or more EDM systems.
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Clinical Data Manager
Pleasanton, CA |
Serves as Project Lead
Responsiiblities
Responsibilities include development of Data Management Plan and Data Management Study File documents.
Initiates comprehensive data management tasks. May make assignments of tasks to team members.
Provides data management expertise and data management process improvement.
Mentors other team members and Leads in training and developing data management expertise.
Independently brings project solutions
Experience
Experience with CDISC, EDC, data development, mapping, cleansing experience
Scientific background good to have
Contact
If you think you are a good match to this position email me a Word doc of your resume' to sparam@us-buxton.com and call Sudha Parameswaran at 925 467 0725.
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