Director, Medical Writing

We need to output HTML fragment with sections: About the role? Actually we need to use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections that have real content. From posting: We have "About Beeline Medicines" description (company overview). That could be "About the role"? Actually "About the role" is a heading for role summary. The posting includes "Job Summary". So we can use

About the role

with paragraph(s) from Job Summary. Then "Essential Duties And Responsibilities" ->

Responsibilities

with list. Qualifications: there is a "Qualifications" section with education and experience etc. Could be

Qualifications

with list. Skills: there are many skill items within qualifications; but we could separate Skills section if there is explicit skills list. The posting includes many skill-like items: "Proficiency with document management systems...", "Strong publication planning experience...", "Proficiency with AI-assisted authoring...", etc. Could be placed under Skills. However we already have Qualifications covering education and experience; we could put skill items under Skills. But we need to avoid duplication. The instruction: Use headings for sections; we can decide to have Qualifications (education/experience) and Skills (technical skills). Let's parse. Qualifications block: 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. Thus many of these are skills. We could split: Qualifications: Education and years experience. Skills: rest. But we need to avoid filler like "varies". Pay section: Salary Range is given: "Salary Range $199,000 - $258,000 USD". Also note earlier line: "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." That's vague; but we have a concrete range later. We should include Pay section only if posting actually states them. It does state a range: $199,000 - $258,000 USD. So we include Pay. Benefits: There's a Benefits section describing benefits package. So include Benefits. Schedule: 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... This is about work arrangement, not schedule. There's no explicit schedule (e.g., full-time, part-time). So we should not create Schedule section because no specific schedule info. Thus sections: About the role (Job Summary), Responsibilities, Qualifications (education+years), Skills (the rest), Benefits, Pay. We need to use

for each section heading. Use

• for any list of duties/requirements/benefits. Use

  for prose. We must not repeat job title as heading. Not include Job ID etc. We must preserve all substantive information; do not invent or summarize away detail. So we need to include all details from each section. We need to be careful not to omit any detail. Let's extract each piece. About the role (Job Summary): Paragraph: "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." We can put that in

  . Responsibilities: list of duties from "Essential Duties And Responsibilities". Need to capture each bullet (they are separated by periods but not bullet list). We'll need to convert to

  • items. Must preserve all info. Let's parse the responsibilities paragraph: "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." We need to split each sentence into separate
  • . Ensure we keep all details. Qualifications: Education and years experience. We have: "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," That's it for qualifications? Actually there is also "Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages." That could be considered qualification but also skill. We'll decide to put under Qualifications: education + years experience. The rest under Skills. But we need to ensure we don't lose any substantive info. So we will put education and years experience as
    • items. Skills: all remaining bullet-like statements. Let's list them: - 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. We'll put each as
    • . Benefits: The benefits paragraph: "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 requirementsFlexible work arrangements / hybrid schedule 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." We need to keep the content. It's a bit run-on; we can split into sentences. We'll make
      • items for each benefit point? The instruction: Use
        • for any list of duties/requirements/benefits. So we can treat each benefit as list item. But the text is not clearly bulleted; we can parse: - 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 - Flexible work arrangements / hybrid schedule - Benefits vary by location and are subject to eligibility requirements