Beeline Medicines

Beeline Medicines

Associate Director, Regulatory Affairs Medical Writing

United States · Director

Sponsorship not specified$193k-$215kDetected 20 days ago
ComplianceProject ManagementVendor ManagementPharmacologyFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationPublic SpeakingBiostatisticsRegulatory Affairs

About the role

  • Remote - This position is designated as remote
  • The frequency and scheduling of such visits will be determined at the company's discretion based on business need.
  • Contribute to shaping the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules.

Responsibilities

  • Author, coordinate, and review 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.
  • Collaborate closely with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs to plan, sequence, and execute document deliverables, coordinating cross‑functional review cycles and ensuring timely, integrated input.
  • Own document timelines and individually or in collaboration with project management, maintain and actively manage integrated trackers across programs, partnering with line management to align on resourcing needs, anticipate and mitigate bottlenecks, and finding creative ways to provide regular, transparent status updates to cross‑functional teams and leadership.
  • Establish a clear process for the authoring, review, QC and approval of regulatory documents to be submitted to heath authorities. Develop training materials for the cross functional team to ensure adoption of the agreed process.
  • Perform other duties and responsibilities as assigned.

Requirements

  • Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required.
  • Minimum of 7+ years of medical writing experience in the pharmaceutical or biotech industry,
  • Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment.
  • Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment.
  • Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable.
  • 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.
  • Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive decision-making.

Nice to have

  • 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 strongly preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas.
  • Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards.
  • 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.

Compensation

  • 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.
  • $193,000 - $215,000 USD
  • Equal Employment Opportunity:
  • We celebrate diversity and are committed to creating an inclusive environment for all employees.

Benefits

  • We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices.
  • 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
  • Specific benefit details applicable to your country or region will be provided during the offer process.
  • Benefits may include, but are not limited to:
  • Flexible work arrangements / hybrid schedule
  • Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.

Company info

  • 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.

Equal opportunity

  • If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation.
  • We are committed to providing equal access to all candidates.
  • Beeline Medicines is an Equal Opportunity Employer.
  • We celebrate diversity and are committed to creating an inclusive environment for all employees.
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This listing is sourced directly from Beeline Medicines's careers page and normalized into a canonical job model.