Director, Medical Writing

Location of role Gaithersburg, Conshohocken, Remote

Department Regulatory Affairs

Key Responsibilities The Director, Medical Writing will take the lead on document strategy, overseeing the authoring and review processes and writing of assigned documents. They will determine appropriate assignments and coordinate both internal writers and external contract writer/writing groups. They will establish best practices to generate high quality preclinical summaries, clinical and regulatory submission documents in compliance with ICH/GCP/regulatory guidelines for global health authority submissions for IND/CTR/CTA/BLA/sBLA, etc.

• Lead planning, authoring, and critical review of regulatory documents as required (e.g., Protocols, CSRs, IB, health authority briefing documents).
• Evaluate/review documents generated by other internal and external writers to ensure consistency with objectives, overall formatting, nomenclature, and scientific approach within and across projects.
• Engagement with external stakeholders such as vendors, thought leaders or other groups as needed.
• Develop and manage timelines for authoring, review and finalization of critical documents and associated deliverables.
• Assess medical writing needs and ensure that each is adequately resourced for timely completion (in house and/or by consultant/CRO support)
• Ensure smooth and effective document management from start to finish (i.e., from template to final approved version), including but not limited to first draft authoring, coordination of review and adjudication, generation of bibliographies, and adherence to the style guide
• Support the development, implementation, and improvement of best practices, the document process, and SOPs as needed
• Develop and maintain templates and outlines for key documents that are not supplied via template supplier. Ensure adherence to templates and enable adjustments, as appropriate for each document(s).
• Leadership of matrix teams
• Track record of developing high-quality preclinical, clinical development, regulatory and scientific documents with experience writing regulatory documents including, but not limited to: protocols, clinical study reports, BLA/NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
• In depth knowledge of drug and biologic development and approval processes and GxP principles
• Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
• Facilitate comment resolution meetings to reach final agreement on approach.
• Ability to manage/prioritize multiple projects and work in a fast-paced environment
• Flexible and able to adapt to changing deadlines and priorities
• Strong written, verbal, and interpersonal communication skills
• Highly attentive to detail
• Self-motivated and able to self-manage effort to maintain alignment with corporate goals
• Proficiency in the use of Microsoft Office applications and experience working in electronic document management systems
• Experience in responding to company and regulatory audits
• Bachelor's degree in a scientific discipline, with advanced degree desirable (MS, Ph.D., PharmD, MD).
• 8-12 years of experience in medical or scientific writing in the pharmaceutical or biotech industry for Bachelor's degree level. 6-8 years’ experience with advanced degree (MS, Ph.D., PharmD, MD)
  
  

About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.