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Director of Medical Writing

Cambridge, MA

Posted: 06/10/2019 Employment Type: Direct Hire Job Category: Clinical: Medical Writing Job Number: 2362

Our Client is looking to add a Director of Medical Writing to their team on a permanent basis. 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.

RESPONSIBILITIES INCLUDE:
  • 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 / QUALIFICATIONS:

 
  • BS required, advanced degree in scientific discipline preferred
  • At least 5 years in medical writing, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA), with supervisory experience
  • 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, 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 biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
  • Independently motivated, and good problem-solving ability
  • Ability to think strategically to further project and departmental development

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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