Director, Medical Writing

  • Location:Cambridge, MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

SUMMARY

Director, Medical Writing is responsible for providing Medical Writing leadership for clinical, nonclinical, and regulatory affairs writing activities by independently developing and delivering timely, high quality documents aligned with the corporate strategy. The Director, Medical Writing must have oversight experience as well as the ability to synthesize scientific content, contribute insight to analysis of data, and advise on strategic presentation of information and present results in a clear, accurate, and consistent format with adherence to regulatory and internal guidelines, styles, and processes. Effective teamwork and strong scientific, interpretive, organizational, and project management skills are critical for this position which reports to the Vice President, Clinical Development Operations.

 

RESPONSIBILITIES

  • Lead and establish the Medical Writing function at Surface Oncology
  • Develop clinical and regulatory documents, ensuring high quality, timeliness, and compliance with internal and external standards
  • Ability to contribute insight to data analysis and advise the team on strategic presentation of results/information to ensure clear communication
  • Ensure a consistent, standardized approach to medical writing across research and development
  • Provide line management, mentoring, and medical writing vendor oversight, as needed
  • Represent Medical Writing on product development teams to advise on strategy, content, and format requirements and coordination of writing activities including timelines and review matrices for document development
  • Plan, prepare, write, edit, format, and finalize clinical and regulatory documents. Documents include, but are not limited to: clinical protocols/amendments, clinical study reports, Investigator’s brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, risk management plans, and regulatory responses
  • Effectively collaborate with Clinical Development, Regulatory Affairs and Research colleagues as well as other relevant Surface functions
  • Participate in developing and implementing standard operating procedures and related processes
  • Ensure compliance, remain informed on regulations and developments in medical writing, and maintain knowledge of product areas, current trends, and current literature

 

REQUIREMENTS/QUALIFICATIONS

  • 10+ years of industry experience as Medical Writer
  • Minimum of bachelor’s degree. Advanced degree preferred
  • Extensive experience writing briefing books, Investigator’s brochures, clinical protocols/amendments, annual reports, and clinical study reports for varying stages of development including summary documents for IND/NDA filings
  • Experience with manuscript, abstract, and poster development; nonclinical writing experience welcomed but not required
  • Extensive people management and oversight experience in an internal and outsourced model
  • Strong understanding of clinical research, the drug development process, and applicable regulatory guidelines for US and non-US regulatory submissions
  • Oncology therapeutic area experience
  • Leadership skills in planning, preparing, managing, and finalizing documents
  • Excellent interpersonal skills and experience in working with cross-functional teams; comprehensive understanding of internal departments and external functions/vendors and the interdependencies of these functions
  • Flexibility/adaptability to work in a fast-paced and dynamic environment
  • Experience with using templates (eg, StartingPoint) and reference programs (eg, EndNote) and proficiency in MS Word, Excel, PowerPoint, Project and Adobe Acrobat
  • Very strong organizational, verbal, written, and presentation skills; meticulous attention to detail
  • Flexible work model, role based in Cambridge, MA
  • COVID-19 vaccination required