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Associate Director, Medical Writing

Cambridge, MA 02142

Post Date: 08/06/2018 Job ID: 1990 Job Category: Clinical: Medical Writing

Our client is seeking an Associate Director, Medical Writing. Reporting to our Vice President, Medical and Technical Writing, the primary deliverables for this role are clinical regulatory documents according to applicable regulations. It is envisioned that this person will play a leadership role in future key regulatory submissions to the FDA and EMA. This will be full time, onsite role.

Job  Responsibilities:
  • Provide leadership in planning and completing key submission documents (e.g., Clinical Summaries of Safety and Efficacy, Clinical Overview) for submissions to the FDA and EMA
  • Contribute to overall project management and to cross functional working groups (clinical operations, clinical development, data management, statistics) as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
  • Manage the work of CRO contract writers, as needed
  • Work with the clinical and regulatory teams to prepare protocols, clinical study reports, Investigator’ s brochures, safety updates, and IND clinical sections in CTD format under strict timelines
  • Participate in recruiting and mentoring of staff, and budget planning


Requirements:
  • PhD in a Life Science or equivalent
  • At least 5 years in medical writing, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA)
  • Experienced in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections
  • Demonstrated ability to communicate and write clearly, concisely, and effectively
  • Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high? quality documents according to tight timelines
  • Wide knowledge of biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
  • Proficient in Microsoft Word; familiarity with Excel, QUOSA, and PleaseReview an advantage
  • Accurate and detail-oriented
  • Aptitude for compilation, analysis, and presentation of data
  • Independently motivated, and good problem-solving ability
  • Ability to work with multiple contributors to produce a final unified document

Julie Monti
Senior Recruiter

Julie brings nearly 20 years of experience to her role as Senior Recruiter for The Steely Group. Throughout her career, she has built lasting relationships and strong partnerships while helping companies build successful teams. Julie is known for her sharp wit, easy smile, sense of humor and genuine interest in people.
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