Associate Director, Medical Writing

Provide strategic and operational medical writing expertise to prepare high-quality complex clinical and regulatory documents for health authority submissions. Contribute to the medical and regulatory writing portfolio and collaborate across functional groups within the company. Lead and maintain standardized document development processes for clinical and regulatory documents. Develop and execute strategies for organizing and preparing documents for clinical and regulatory health authority submissions. Independently author and/or lead the authoring and end-to-end development of clinical and regulatory documents. Write, review, and edit science-based documents such as those included in IND/NDA sections. Provide high-quality medical writing support to documents led by other company functional groups. Manage contract medical writers, as needed, and review documents produced by external writers. Collaborate with relevant company subject matter experts and document owners to develop content. Collaborate with cross-functional teams to ensure development of high-quality accurate documents delivered on time. Contribute to the development of templates, SOPs, and company style guide to ensure quality and consistency of documents across programs. Responsible for inspection-readiness of medical writing activities. Maintain up-to-date knowledge of global regulatory guidance and industry best practices. Requirements Advanced degree in life sciences; PhD preferred. At least 5-8 years of sponsor-level biotechnology or pharmaceutical clinical/regulatory medical writing experience required. Extensive experience in oncology-focused medical writing, with significant exposure to regulatory submissions. Recent direct or supportive NDA experience with clinical and regulatory documents, including authoring eCTD Module 2 clinical summaries (m2.7.2, m2.7.3, or m2.7.4) and/or overviews (m2.5), and Assessment Aid. Significant experience with authoring protocols and amendments, Investigator Brochure annual updates, CSRs, and DSURs. Must have strong analytical and critical thinking skills, strong attention to detail, ability to interpret and clearly present clinical data and other complex information, and an internal drive to produce clear and thorough, accurate, and high-quality documents. Commitment to clearly understanding data and text, including proactively reaching out to medical writing senior management and/or subject matter experts to enable authoring clear and concise summary text that is understandable to reviewers from various backgrounds and experience. Strong expertise in interpreting and synthesizing safety and efficacy data into meaningful insights and summaries. Strategic thinker with a big-picture orientation. Strong project management and leadership skills; ability to coordinate the efforts of team members according to timelines, and manage competing priorities. Excellent written and verbal communication skills. Exceptional partnership and collaboration skills. Able to prospectively identify potential problems and to partner effectively and positively to solve issues. Understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission. Knowledgeable in the regulatory guidance documents developed for documents authored by medical writing. Ability to work independently, as well as collaboratively in a team. Excellent time management skills and a proven ability to prioritize and work on multiple projects at any given time. Working knowledge of AMA style, lean authoring, and regulatory document formatting conventions. Expert in MS Office/Microsoft 365. Experience with Veeva Vault preferred. ATS Optimization Keywords Below are skills and terms extracted directly from this job posting to improve Applicant Tracking System (ATS) visibility. This unique feature helps candidates tailor their applications more effectively — a feature exclusive to JobTailor job listings. Hard Skills Medical Writing Regulatory Submissions ECTD Module Authoring Protocol Authoring Clinical Data Interpretation Document Development Processes SOP Development Safety And Efficacy Data Synthesis Time Management Scientific Methodology Soft Skills Analytical Skills Attention To Detail Communication Skills Collaboration Skills Problem-Solving Skills #J-18808-Ljbffr Jobtailor