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System One Director, Team Lead, Medical Writing in Plainsboro, New Jersey

Director, Team Lead, Medical Writing

This is a supervisory role, and experience managing a medical writing team in an oncology setting is required.

Must have:

  • At least 12 years’ experience as a clinical or regulatory medical writer in the pharmaceutical industry

  • Oncology experience is required

  • Protocol-writing experience (Phase 1-3)

  • Experience writing/leading the writing of clinical documents in regulatory filings (NDA, BLA, MAA, J-NDA), and experience writing clinical trial outlines, investigator’s brochure, CSRs, briefing documents, PIPs, DSURs, and other clinical documents to support the conduct of the trials and regulatory submissions/filings

  • Familiarity with all phases of the drug development processes (discovery to market), clinical study protocol design, the CTA/IND submission process, plans required for the conduct of clinical studies, and clinical study data collection and results reporting

  • Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.

  • Proficiency in the use and understanding of computer software eg, word processing, graphics, reference manager, EndNote, document management systems.

  • Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).

  • Ability to interpret and summarize complex tabular and graphical data presentations.

    Personal requirements:

  • Capable of working on multiple complex tasks and shifting priorities, and leading cross-functional teams under strict timelines.

  • Motivated and detail-oriented.

  • Ability to work across all trial phases and prioritize your own tasks.

  • Dedicated team player and a great communicator with excellent oral and written communication skills.

  • Proactive and open-minded.

  • Quality mindset and thrive in a fast-paced and changing environment.

  • Result- and goal-oriented and committed to contributing to the overall success

    Key Accountabilities

  • Manage, coordinate, develop, supervise, and support 5-7 Medical Writers

  • Support the assessment of resources needed for upcoming trials and projects

  • Contribute to the continued building of a framework within the Medical Writing department focusing on growth and development of new and “innovative” ways to work with internal and external partners in a global context utilizing a mixed in-sourced/outsourced model

  • Independently, and expertly, draft clinical trial outlines, clinical trial protocols/amendments, investigator’s brochure, CSRs, briefing documents, PIPs, DSURs, clinical regulatory submission documents, and other clinical documents to support the conduct of the trials and regulatory submissions/filings

  • Drive trial team participation in the preparation of such documents, including calling/scheduling/facilitating meetings, developing and managing timelines, document review, and decisions

  • Provide peer review and editing support for other clinical/regulatory documents, as needed

  • Adhere to guidelines, SOPs, and practices and technical and industry standards during all aspects of work

  • Proactively support developing and reviewing standard processes and templates

  • Work effectively and lead in cross-functional working groups

    Director, Team Lead, Medical Writing with a minimum of 12 years’ relevant medical or scientific writing experience in the Pharmaceutical Industry (oncology experience required). In this newly created position, the Director, Team Lead, Medical Writing, will be a member of the Medical Writing Leadership team and actively contribute to driving the overall strategy and identifying development areas within Medical Writing to ensure that the Medical Writing group works toward the same objectives and as one team. The successful candidate will have prior people-management experience, strong analytical skills, high quality standards, and be committed to meeting deadlines. In addition, it is essential that you are well-organized, proactive, and flexible, and have the ability to work on multiple complex tasks simultaneously.

    As Director, Team Lead, Medical Writing you manage a staff of 5-7 medical writers. You will help manage the medical writing portfolio within the clinical and regulatory area, including, but not limited to clinical trial outlines, clinical trial protocols/amendments, investigator’s brochures, CSRs, briefing documents, PIPs, DSURs, clinical regulatory submission documents, and other clinical documents to support the conduct of the trials and regulatory submissions/filings. As an independent contributor, you may also serve as a Lead Writer on a compound, responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the company portfolio by ensuring that scientifically robust messages and arguments are developed and conveyed consistency across documents. Ideally, you will have an academic degree in the life sciences or related area with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.

    Position will be involved in strategic project, as well as trial and compound-related activities, and will have ample opportunities, responsibilities, and influence on defining your own work. Will be involved in leading the development of processes and tools to support further development of the department.

    Reports to the Senior Director, Head of Medical Writing and Clinical Trial Operations Processes.

    Work from home/some office expectations

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