Overview

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 candidates are expected to be on-site 2 days per week.

Responsibilities

Key responsibilities:

• Responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of a clinical program
• Working knowledge of BLA/MAA submissions and experience using document management systems
• Ensure consistent information and messages are implemented within individual documents
• Advise on strategic document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs)

• Coordinate preparation, editing, and finalizing protocols, investigator brochures, synopses, clinical study reports, regulatory documents
• Collaborate with the regulatory operations staff for document lifecycle management and approvals
• Collaborate with the clinical and scientific staff for narrative and data presentation planning, gather material for relevant documents and ensure that documents accurately reflect sources
• Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
• Prepare abstracts, posters, presentations, and manuscripts; assist in the development and maintenance of quality and product documentation as needed and agreed to
• Advise and assist in the review and management of nonclinical and CMC technical reports as needed.
• Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are stored in appropriate document management system(s)

Qualifications

Educational requirements:

• Bachelor’s degree in medical-related field or life science required; post-graduate degree (master’s or doctoral) preferred

Experience and skill requirement:

• 7 years’ experience in a medical writing capacity within drug development
• Ability to mentor and influence junior staff members
• Thorough knowledge of clinical research concepts, practices, and FDA/EMA regulations and ICH/GCP Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Experience working with CROs, vendors, and relationship management. Experience interacting and communicating timeline expectations with cross functional study team members
• Ability to communicate highly complex ideas, anticipate potential objections, interact with senior leaders, and apply advance negotiation skills
• Experience with electronic document management systems
• Highly proficient in the functionality of MS Word, Excel, Endnote, Adobe Acrobat, and PowerPoint
• Familiarity with statistical analysis concepts and techniques preferred

Location: 

• This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.