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Manager/Sr. Manager, Medical Writing

Cambridge, Massachusetts 02142

Post Date: 03/07/2018 Job ID: 1871 Job Category: Clinical: Medical Writing, Clinical: Regulatory

As an integral part of the clinical team, the Sr. Manager/Manager of Medical Writing develops Clinical and Regulatory documents, ensuring the documents are of high quality and comply with internal and external standards. The Sr. Manager/Manager of Medical Writing should be able to contribute insight to the analysis of data and advise the team on strategic presentation of results/information to ensure clear communication with external readers. The Manager of Medical Writing will be an integral team member of registration dossiers, contributing to the development of Module 2 summary documents.

If the incumbent will be working in a remote capacity, the requirement is that they work on site in Cambridge, MA for the first week of employment, followed by working onsite 2-3 days every other month.

Job Responsibilities:
  • Plan, prepare, write, edit, format, and finalize clinical and regulatory documents. Documents will include, but are not limited to: clinical protocols, clinical study reports, Investigator brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, risk management plans, and regulatory responses.
  • Coordinate the internal review of documents.
  • Effectively collaborate with Clinical Research and Development colleagues, along with other departments including, but not limited to, regulatory, safety, biostatistics, clinical operations, biology, medical affairs, and the commercial group.
  • Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (e.g., timelines and review/revision responsibilities) with the project teams.
  • To ensure compliance, remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature.

Qualifications/ Requirements:
  • Ph.D. or similar advanced degree in a relevant scientific field
  • 4+ years of industry experience as Medical Writer
  • Experience in Psychiatry/Neurology/Oncology therapeutic areas
  • NDA experience with active contribution in planning and preparation of summary documents
  • In-depth experience in US and Non-US Regulatory submissions
  • Experience in working with cross-functional teams
  • Excellent interpersonal and communication skills
  • Flexibility/adaptability to work in a fast-paced and dynamic environment
  • Candidates must be authorized to work in the U.S.

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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