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Summary of job description:
Leads cross-functional teams (including representation from the clinical development, regulatory affairs, biometrics, quality and translational research departments) in the planning and preparation of high quality clinical and regulatory documents. The Senior Manager, MW will provide writing assistance on various documents, including clinical study protocols and amendments, Investigator’s Brochures (IBs), clinical study reports (CSRs), Development Safety Update Reports (DSURs), and other documents, as needed. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this position. The MW must be able to summarize information provided in graphical or tabular formats. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.
The Director, Medical Writing will work collaboratively with Replimune’s regulatory, clinical, and scientific teams to produce high quality documents to support the company’s drug development programs. They will focus on the preparation of regulatory and clinical documentation for submission to global regulatory agencies and assist with the preparation of publications, abstracts, and other external and internal communications as needed.
This position is based in our Woburn office and welcomes hybrid work! Local candidatesare expected to be on-site 2 days per week.