Senior Manager, Medical Writer

Role Summary

As Senior Manager, Medical Writer, you will lead or make key contributions to clinical and regulatory documents within our organization. You will be responsible for medical writing strategy and timely deliverables for one or more projects or programs. You will be responsible for authoring clinical, nonclinical and regulatory documents. You may be responsible for oversight or general assistance to medical writing consultants and other writers.

Responsibilities

• Lead projects, submissions or programs independently.
• Provide medical writing strategy to program teams, ensuring business goals and regulatory needs are met.
• Author key clinical, nonclinical and regulatory documents, including but not limited to clinical study protocols, amendments, IBs, CSRs, data summaries, CTD summaries, briefing books and meeting responses.
• Develop timelines in collaboration with our team. Plan for required data with SMEs, if applicable.
• Co-author documents with relevant cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments).
• Coordinate QC, finalization and publication of documents
• Review or contribute to supporting study documents, including but not limited to informed consent forms, study charters, or pharmacy manuals, if required.
• Ensure key messages are clear and consistent across and within documents.
• Represents the medical writing function in cross-functional teams.
• Provide status updates to keep teams, department, and leadership informed.
• Identify risks and contribute to risk mitigation or contingency planning for submission activities.
• Proactively contribute to process improvements and standards across the team. Develop or maintain document templates, job aids, tools, and training materials.
• Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.

Qualifications

• Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MS, PhD, MD, PharmD) is a plus.
• A minimum of 8+ years of experience in relevant regulatory medical writing is required.
• Proven track record of program- and/or submission-level management
• Ability to manage multiple projects and timelines simultaneously
• Proven track record of leading and authoring high-quality clinical and regulatory documents, including for complex document types.
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.
• Knowledge of drug-drug and biologic-biologic combination products as well as the design of clinical studies for such products is a plus.
• Excellent leadership, collaboration, communication, and interpersonal skills (taking initiative, problem solving, conflict resolution, change management, strategic thinking).
• Ability to meet deadlines and adapt to changing priorities.
• Expert in word processing software (e.g., Office) and document management systems (e.g., Veeva).

Skills

• Medical writing strategy
• Project management
• Cross-functional collaboration
• Regulatory understanding (FDA, EMA, ICH)
• Documentation development (protocols, IBs, CSRs, data summaries, CTD summaries, briefing books)
• Quality control and publication processes
• Templates, tools, and training material development
• Lean authoring and strategic review

Education

• As listed in Qualifications

Additional Requirements