Director, Medical Writing

Beeline Medicines; United States; On-site; USD 199,000 - 258,000; Full time

Job summary

Beeline Medicines is seeking a Director, Medical Writing to lead the design and execution of regulatory, nonclinical and clinical documents across our I&I pipeline. The role blends hands-on writing with people leadership, vendor management, budget forecasting, and process development to ensure high-quality, regulator-ready deliverables.

You will partner with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs and external writers to plan, author, review, and deliver INDs,

Qualifications

• 10+ years of medical writing experience in pharma/biotech.
• Experience overseeing regulatory submissions in ICH CTD format (CSRs, ISS/ISE, IBs, IND/CTA).
• Strong ability to lead and mentor multi-disciplinary teams.
• Excellent written and verbal communication with stakeholders.

Responsibilities

• Lead day-to-day medical writing activities for regulatory and clinical documents.
• Define submission narratives and ensure content consistency across CTD modules.
• Oversee planning, timelines, and review cycles across programs.
• Manage internal staff and external vendors, including budget ownership.
• Develop SOPs, templates, and training to ensure regulatory compliance.

Skills

Regulatory writing

Medical writing leadership

IND/CTA submissions planning

FDA/EMA guidelines

Vendor management

Budget management

Cross-functional collaboration

ICH CTD familiarity

CTD modules coordination

Editorial leadership

Education

Advanced degree (PhD, PharmD, or master's) in life sciences

Tools

Veeva Vault

Document management systems

Publishing platforms

Job description

Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

Job Summary:

The Director, Medical Writing is a hands-on leadership role responsible for clear scientific messaging and for the development, coordination, and delivery of high-quality regulatory, nonclinical, clinical, and other scientific documents in support of the company's I&I pipeline. This position combines active document authorship with functional leadership of medical writing, ensuring that deliverables meet high standards of scientific accuracy, regulatory compliance, and clarity.

The Director owns the design and implementation of medical writing processes, templates, and standards, builds and manages internal writing capability, and directs the selection, oversight, and performance of external writing vendors within an agreed budget. The role partners closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external vendors to plan, author, review, and deliver documents supporting critical regulatory milestones, including INDs, amendments, briefing packages, and selected NDA/BLA components.

This role is expected to remain closely involved in the hands-on execution of core documents while carrying accountability for people management, vendor and budget management, and delivery across multiple concurrent programs as submission activity expands.

Work Arrangement & Location:

Remote - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Essential Duties and Responsibilities:

• Own day to day execution of medical writing activities, authoring, coordinating, and reviewing key clinical and regulatory documents, including protocols and amendments, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components, ensuring scientific accuracy, regulatory compliance, and consistency of content.
• Contribute to defining the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules. Represent Medical Writing in cross functional and governance forums and drive alignment on submission strategy and document readiness.
• Direct planning and sequencing of document deliverables with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs; own integrated timelines and trackers across concurrent programs, coordinate cross functional review cycles, anticipate and mitigate bottlenecks, and provide regular, transparent status updates to cross functional teams and leadership.
• Manage and develop medical writing staff and contract writers.
• Manage medical writing vendors, including selection, scope definition, deliverable tracking, quality oversight, and performance review. Own the Medical Writing budget and forecast internal FTE and vendor capacity against the program plan.
• Establish, document, and maintain the process for authoring, review, QC, and approval of regulatory documents submitted to health authorities, including SOPs, style guides, and templates aligned with ICH and regional requirements. Develop and deliver training to the cross functional team to ensure adoption of the agreed process.
• Support Health Authority briefing documents, meeting request packages, and written responses to Agency queries.
• Manage the Medical Writing function budget and resource planning, including FTE capacity and vendor utilization forecasting.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required.
• Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry.
• Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages.
• Deep scientific expertise in immunology, inflammation, or autoimmune disease is preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas.
• Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment.
• Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards.
• Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment.
• Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent.
• Strong publication planning experience, including familiarity with ICMJE authorship guidelines, journal submission processes, and scientific congress submission requirements.
• Proficiency with AI-assisted authoring and review tools applied to regulatory and clinical documents is strongly preferred, including practical understanding best prompt practices, limitations, quality control requirements, and appropriate use in a regulated environment.
• Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable.
• Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
• Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
• Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.
• Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and board-level stakeholders.

Salary Range:

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$199,000 - $258,000 USD

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation:

If you require a reasonable accommodation to participate in the application or interview process, please contact [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines