United States onlyDepartment: Regulatory Affairs
Reports To: VP, Regulatory Affairs
Status: FTE
About vTv
vTv Therapeutics is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications, including type 2 diabetes and other chronic conditions.
Description
vTv is seeking a Director/Senior Director, Medical Writing to lead the strategy, development, and delivery of high-quality clinical and regulatory documents supporting our global clinical development programs - including clinical study protocols, investigator brochures, clinical study reports (CSRs), briefing documents, INDs, NDAs/BLAs, MAAs, safety reports, and scientific publications.
This role partners closely with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, and other functional teams to ensure the timely preparation of scientifically rigorous and regulatory-compliant documents across the product lifecycle.
The Director/Senior Director serves as the medical writing lead for major development programs, ensuring alignment of messaging and scientific integrity across regulatory submissions, clinical documentation, and external communications.
This is a unique opportunity to contribute to the development of a potential first-in-class therapy in diabetes, working in a collaborative and science-driven environment. This position is fully remote.
Key Responsibilities
- Medical Writing
- Provide strategic leadership and oversight of the Medical Writing function, ensuring the delivery of high-quality clinical and regulatory documentation.
- Establish document standards, templates, style guides, and best practices aligned with regulatory expectations (ICH, FDA, EMA).
- Oversee document planning, timelines, and resource allocation across programs to ensure on-time delivery of key regulatory and clinical deliverables.
- Lead identification and management of external medical writing vendors and consultants as needed.
- Maintain awareness of evolving regulatory guidance and industry best practices relevant to clinical and regulatory documentation
- Supervise (directly or indirectly) a team of medical writers and external writing vendors, and may recruit, manage, mentor, and develop writing staff.
- Clinical and Regulatory
- Serve as the medical writing lead for assigned development programs, partnering with clinical, regulatory, and statistical leaders providing strategic guidance and development to ensure clear and consistent scientific communications.
- Lead the preparation and review of major clinical documents as applicable, including:
- Clinical study protocols and protocol amendments
- Clinical study reports (CSRs)
- Investigator brochures (IBs)
- Safety narratives
- Scientific manuscripts and conference abstracts
- Ensure scientific accuracy, clarity, and consistency across clinical documents.
- Collaborate with cross-functional teams to present complex clinical and scientific data into clear, regulatory-compliant documents.
- Manage clinical development processes and document archival requirements
- Provide strategic input into regulatory submissions, ensuring consistency of messaging across documents and alignment with regulatory strategy.
- Support preparation of documents for regulatory meetings with agencies (e.g., FDA Type B meetings, End-of-Phase meetings, advisory committees) and major regulatory documents, including IND, CTA, NDA/BLA, and MAA submission components (e.g., ISS/ISE summaries, Module 2 documents, Clinical overviews, etc.)
- Leadership
- Serve as the strategic medical writing representative on program teams and development governance committees.
- Provide expert guidance on document strategy, messaging, and expectations.
- Contribute to corporate initiatives related to scientific communication, publication strategy, and document quality standards.
- Mentor internal staff and foster a culture of scientific rigor, clarity, and excellence in medical writing.
- Represent vTv on high impact/priority task forces across vTv or external to the company.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Advanced degree preferred (MS, PhD, PharmD, MD, or equivalent scientific discipline preferred).
- 12–15+ years of medical writing experience within the pharmaceutical or biotechnology industry, CRO, or related environment.
- Extensive experience preparing clinical and regulatory documents supporting INDs and NDAs/BLAs.
- Demonstrated leadership of complex cross-functional writing projects and submission programs.
- Experience managing medical writing teams and external vendors preferred.
Skills
- Exceptional scientific writing and editing ability.
- Strong strategic thinking and problem-solving skills.
- Ability to translate complex scientific data into clear, concise, and regulatory-compliant documentation.
- Strong cross-functional leadership and collaboration skills.
- Excellent communication and interpersonal skills with the ability to influence multidisciplinary teams.
Knowledge
- Expert knowledge of ICH guidelines and global regulatory submission standards.
- Familiarity with FDA and EMA expectations for clinical documentation and regulatory submissions.
- Experience with word templates, electronic submission formats (eCTD) and document management systems.
LICENSES/CERTIFICATIONS:
- None required
- AMWA certification preferred but not required.
TRAVEL REQUIREMENTS:
- Ability to travel occasionally for internal meetings, regulatory interactions, or scientific conferences.
- Requires approximately 5 - 10% travel.
- This is remote position
