Director, Medical Writing

Vacancy Name
Director, Medical Writing

Vacancy No
VN640

Employment Type
Full Time

Location of role
Gaithersburg, MD, Radnor, PA

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., Pharm

D, 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., Pharm

D, MD)

$157,500- $262,500

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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…