Monday, April 5, 2010

Regulatory Writing Position

Responsible for researching, writing, and editing materials for regulatory submission. As a member of the medical communications team, relies on instructions and pre-established guidelines to perform the functions of the job.

Essential Functions:

Primary responsibilities are as follows:

1. Works with data management and clinical operations groups to review and interpret clinical trial data
2. Compiles, writes, and edits regulatory materials (IND/NDA), with specific emphasis on clinical study reports, investigator brochures, and SAE narratives
3. Assists other writers in the compilation, writing, and editing of regulatory materials
4. Manages review and revision processes for multiple, concurrent projects
5. Ensures quality of content and format of publications in accord with applicable regulations, guidelines, and corporate SOPs

Skills Required:

1. Knowledge of FDA regulatory requirements, Good Publication Practice (GPP) and ICH guidelines, including strong familiarity with the eCTD
2. Strong medical and/or scientific writing skills
3. Ability to work well in a team environment, with the ability to work effectively independently
4. Efficient project management skills
5. Good work ethic

Education or Equivalent Experience:

• Bachelor’s degree in applied or life science or communications, with a 3-5 years of medical, regulatory, or clinical writing experience in the pharmaceutical or biotech industry, or equivalent training and work experience. An advanced degree is preferred. Ophthalmology experience a plus.

Remuneration based upon experience.


If interested, please forward résumé and salary requirements to

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