SR Manager/AD Medical Writing

Key Responsibilities
Lead or contribute to the preparation of clinical documents, including but not limited to protocols, CSRs, DSURs, IBs, safety narratives, and related appendices.

Collaborate cross-functionally with Clinical Operations, Regulatory, Safety, and Biostatistics to ensure alignment and accuracy across all deliverables.

Manage multiple writing projects concurrently, including oversight of external medical writers and vendors.

Drive the development and review process, coordinating team input and facilitating resolution meetings to finalize high-quality documents.

Ensure compliance with ICH guidelines, internal SOPs, and document templates, maintaining consistency in content, tone, and structure across deliverables.

Perform and/or oversee quality control (QC) checks, ensuring accuracy in data interpretation and presentation.

Support the ongoing development of internal processes, style guides, and training materials to improve writing standards and efficiency.

Represent Medical Writing in cross-functional meetings and contribute to strategic planning for clinical documentation.

Provide mentorship and guidance on writing best practices and regulatory expectations.

Qualifications
Education:

Advanced degree in a scientific, medical, or related field strongly preferred (MS, PhD, PharmD, or MD).

Experience:

Minimum 5 years of experience in medical writing within the biotech or pharmaceutical industry.

(Minimum of 1 year required for candidates with advanced clinical/scientific degrees.)

Oncology experience strongly preferred.

Proven ability to produce high-quality regulatory and clinical documents in alignment with industry standards.

Proficiency in Microsoft Word and experience working within electronic document management systems.

Demonstrated ability to manage timelines, adapt to changing priorities, and work independently or as part of a cross-functional team.

Excellent communication and interpersonal skills, with the ability to manage feedback and resolve editorial differences tactfully.

This role is ideal for someone who enjoys both the strategic and hands-on aspects of medical writing, and who is motivated by the opportunity to contribute to innovative therapeutic development in oncology and other areas of high unmet need.