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Senior Medical Writer

Cambridge, MA

Posted: 02/10/2021 Employment Type: Direct Hire Job Category: Clinical: Medical Writing Job Number: 2508

Job Description

Our client is looking to add a Senior Medical Writer to their team on a permanent basis. This is a newly created position and the primary deliverables for this role are writing clinical regulatory documents according to applicable regulations.

  • Support development of oncology compounds by providing medical writing expertise to cross-functional project teams
  • Lead development of high-quality, logical, accurate clinical, regulatory, and pharmacovigilance documents (clinical study protocols and amendments, study reports, investigator’ s brochures, safety reports, briefing packages, clinical summary documents) under tight timelines and with minimal oversight
  • Review study-related and regulatory documentation for consistency in presentation and messaging across a clinical development program

Requirements / Qualifications:
  • BS required, advanced degree in scientific discipline preferred
  • At least 5 years in medical writing with experience in oncology, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA)
  • Experienced in the preparation of clinical, regulatory, and pharmacovigilance documents
  • Demonstrated ability to communicate and write clearly, concisely, and effectively, with an aptitude for compilation, analysis, and presentation of data
  • 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 development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
  • Independently motivated and good problem-solving abilities
  • Ability to think strategically to further project and departmental development

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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