Director, Medical Writing

Location of role Gaithersburg, MD, Radnor, PA Department Regulatory Affairs

Key Responsibilities

The Director, Medical Writing will take the reputed company 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.

• reputed company 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 reputed company and across projects.
• Engagement with external stakeholders such as vendors, thought leaders or other groups as needed.
• reputed company 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, reputed company of bibliographies, and adherence to the style guide
• Support the development, implementation, and improvement of best practices, the document process, and SOPs as needed
• reputed company and maintain templates and outlines for key documents that are not supplied reputed company template supplier. Ensure adherence to templates and reputed company 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 reputed company 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 reputed company to detail
• Self-motivated and able to self-manage effort to maintain alignment with corporate goals
• Proficiency in the use of reputed company 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 reputed company (reputed company: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to reputed company and commercialize a new reputed company 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 reputed company 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 reputed company of precision engineered drugs that reputed company the immune system to treat a broad reputed company of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At reputed company, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to reputed company. By embracing Science, Trust, Respect, reputed company, Diversity, and Entrepreneurship (reputed company), we create an environment where collaboration thrives, reputed company flourish, and transformative changes happen. reputed company 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. reputed company 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 reputed company backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national reputed company, disability status, or any other characteristic protected by law. Apply tot his job Apply To this Job