Associate Director, Medical & Regulatory Writing

The Role

The Associate Director, Medical & Regulatory Writing serves as a subject matter expert in the writing and production of clinical documents such as the writing of clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. This role is also accountable for Clinical Trial Transparency & Disclosure (CTD) responsibilities and oversight of vendors carrying out such work. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in oversight of external vendors. There needs to be a very strong understanding of document timelines as planning is critical.

Key Responsibilities

• Serves as the assigned medical writer and subject matter expert in preparing clinical regulatory documents through all phases of clinical research.
• Execute clinical trials transparency and disclosures (CTD) book of work and provide vendor oversight.
• Collaborates with cross-functional teams to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
• Works closely with the study team to reach consensus on timelines for deliverables.
• Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement, and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• Represent medical writing in cross-functional team meetings.
• Collaborate with department heads and staff members of cross-functional groups to deliver documents with high quality on time.
• Lead the development of overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary.
• Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents.
• Ensure lean writing practices for regulatory documents such as Clinical Trial Protocols, Investigator’s Brochures, Informed Consent templates, and Clinical Study Reports to minimize CCI and PPD.
• Analyze, validate, and prioritize complex and dynamic information from a diverse range of sources in response to technical and operational challenges.
• Manage, track, and present assigned book-of-work, compile and report performance metrics.
• Manage the preparation of plain language (layperson) synopses and summaries and redaction of clinical documents in accordance with FDA requirements, EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations.
• Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends, as well as requirements for layperson summaries and clinical study diversity planning.
• Coordinate efforts of cross-functional teams to produce documents and postings (e.g., plain language summaries, interim and/or results postings, and redaction documents), acting as liaison between the vendor and internal teams.
• For relevant trials, collaborate with internal and external stakeholders to develop and implement diversity action plans in accordance with FDA guidance.
• Work on multiple projects across programs, coordinating work plans that align with corporate timelines and strategic plans.
• Oversight of vendors in the Clinical Trial Transparency and Disclosure space.
• Must have proficiency in the use of Veeva or equivalent IT software for document creation, review, and QC, including applications for citation of literature references and creation of lists of references in Word documents.
• Maintain current knowledge of industry trends and best practices for medical writing.
• Performs other duties as assigned.

Job Specifications

• A Masters or advanced degree in a scientific, medical, or clinical discipline (e.g., PhD, PharmD, or equivalent) is required. A PhD degree is preferred.
• Must have a minimum of 8-10 years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment. Must have CTD experience, vendor oversight a plus. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochures. Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus.
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements, and guidance associated with document preparation and submission.
• Ability to manage competing priorities in a fast-paced environment.
• Excellent problem-solving, organizational, and analytical critical thinking skills.
• Excellent written and verbal communication skills.
• Strong attention to detail related to consistency, grammar, syntax, and formatting.
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools is a plus.
• Proficient in MS Office Suite, EndNote, and Adobe Acrobat.
• Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva.
• Ability to travel up to approximately 10% of the time.
• Makes decisions for assigned programs or functional areas, balancing priorities and resolving routine challenges; escalates high-impact or cross-functional decisions as needed.
• Facilitates cross-functional coordination for assigned programs or initiatives, ensuring alignment and timely execution of deliverables.