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Search for Jobs by Sheryl Horowitz

Medical Writer (Science & Biotech)
Cambridge , MA 02142
Recruited by: Sheryl Horowitz | Recruiter | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Oct 30, 2022
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Job Description

Our client, a growing international pharmaceutical/biotech company is looking for an experienced Medical Writer to join their team! This is a full-time opportunity with competitive compensation and benefits package.

The key responsibilities in this position will be to perform medical writing tasks for clinical development project related activities including but not limited to preparation of Clinical Development Plan (CDP), Clinical Trial Protocol(CTP), Clinical Trial Reports (CTR), Layperson Summary (LPS), Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries and Clinical overviews. Your primary task will serve as a writer for important clinical and regulatory documents and key components of regulatory submissions, as well as responses to regulatory agencies/ health authorities. The tasks, to a large extent, will have to be performed independently with minimal supervision. This position will need to communicate the clinical data and strategy a clear and concise manner and will also communicate across various time zones.

This job requires good communication and analytical skills. In order to meet timelines, the medical writer must be good at planning their own work schedule. They should proactive when problems arise and seek help and advice from relevant people within cross functional team as well as CROs/external experts.

Candidate Qualifications and Experience:

You are expected to have the below skills and knowledge:

• Graduate (PhD, MSc., M Pharm, or equivalent)

• 2+ years of experience as medical writer or other relevant work experience

• Experience working within a global setting

• Experience from the pharmaceutical /CRO industry

• Strong understanding of external requirements related to regulatory documents

• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas