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Requisition Number: 07-0091
Post Date: 7/31/2007
Title: Medical Writer
City: Novato

BioMarin Pharmaceutical develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions, focusing on product candidates that:

• Address currently unmet medical needs (the “orphaned diseases”, including genetic ones
• Suggest a clear-cut development profile
• Provide an opportunity to be first-to-maket.

SUMMARY DESCRIPTION

The Medical Writer participates as a member of clinical teams, serves as team specialist in clinical documentation, and drafts and edits documents needed to support clinical research studies.

RESPONSIBILITIES

In collaboration with key contributors, writes, edits, and formats clinical regulatory documents (principally protocols, informed consent forms, and clinical study reports) that conform to global regulatory submission and internal document standards. Assists in the development and maintenance of document templates and guidelines that conform to document specifications and internal publishing requirements for regulatory filing. Assists in development and update of SOPs for developing regulatory documents for clinical research.

EDUCATION

Requires a BS or higher degree in a scientific discipline. Evidence of professional development in medical writing or editing (such as AMWA or BELS certification) preferred. Evidence of professional development in the area of regulatory documentation (classes, workshops, or certification) preferred.

EXPERIENCE

A minimum of one to three years of experience writing documentation for clinical trials for a pharmaceutical, biotechnology, or contract research company, or university medical center. Requires a BS or higher degree in a scientific discipline and a minimum of 2 years experience with a BS, at least 1 year of experience with an MS or higher degree, and demonstrated working knowledge of scientific principles.

Skills:

• Must have excellent writing, editing, and oral communication skills.
• Familiarity with clinical regulatory documentation requirements.
• Ability to research and review clinical content effectively and translate information into clear and concise messages using AMA style in the English language.
• Ability to successfully organize and manage multiple simultaneous projects from conception to completion, working collaboratively in a team environment; to communicate effectively in a fast-paced setting; and to re-prioritize writing tasks quickly.
• Proficiency in Word, Powerpoint, and Excel, and familiarity with document management software (eg, Documentum or Livelink)

To apply:
https://www.ultirecruit.com/bio1001/jobboard/CanLogin.aspx?__JobID=*E06D9956873F0202&__RT=*2121BF73EBC1EF25B67FA995E21A6E9BACA95A9A2724AC61608FE054DFA4E05AC2BFB754C55FD045