Senior Director, Medical Writing

Senior Director, Medical Writing

The Senior Director, Medical Writing will lead all clinical and regulatory medical writing activities in support of clinical development including Biologics License Application (BLA) filings. This critical role will be responsible for establishing the medical writing function within a pre-commercial biotechnology organization and ensuring the timely delivery of high-quality regulatory documents to support global submissions.

Reporting to the VP. Clinical Operations, this individual will develop the medical writing strategy, oversee internal and external writing resources, and drive execution across clinical and regulatory programs. The role will be instrumental in preparing the organization for successful BLA and other global filings, with a strong focus on compliance with Good Clinical Practice (GCP), Good Documentation Practice (GDP), and global regulatory requirements.

Your role

Strategic Leadership
  • Build and lead the global medical writing function to support clinical development programs through BLA submission and beyond.
  • Develop and implement a strategic plan for the company’s medical writing activities, ensuring alignment with clinical development, regulatory affairs, and overall business goals.
  • Define and implement a scalable medical writing strategy, including internal capabilities and external vendor partnerships.
  • Develop and manage a fit-for-purpose operating model, including processes, technology tools, and functional standards.
  • Partner with cross-functional leaders in Regulatory, Clinical Development, Clinical Operations, Biostatistics, and Quality to ensure submission readiness and alignment on documentation needs and timelines.
  • Establish performance standards and provide leadership, mentoring, and oversight to writing staff and vendors.
  • This role will be responsible for coordinating the review cycles of documents, managing all aspects of document development, and leading the project teams through the process, including any discussions on document revision, QC, and finalization.
  • Collaborate with clinical development, regulatory affairs, biometrics, and related cross-functional teams to gather and integrate data into regulatory documents.
BLA and Regulatory Submission Readiness
  • Lead the planning, authoring, review, and finalization of core regulatory submission documents, including:
    • Clinical Study Reports (CSRs)
    • Module 2 (Clinical Overview and Clinical Summaries) and Module 5 documents for the BLA 
    • Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) 
    • Risk Management Plans, diversity plans, pediatric plans, and briefing documents
    • Annual reports and IND amendments 
    • Investigator Brochures (including IB updates) and annual DSURs, PSURs, PBRERs as appropriate
  • Support Clinical Development in authoring, review, and finalization of protocols and protocol amendments, including quality review and publication readiness.  
  • Ensure consistency, accuracy, and compliance with ICH, FDA, and EMA guidelines in all regulatory documentation.
  • Drive document strategy discussions, timelines, and workflows to ensure all components of the BLA and all regulatory submissions are delivered on time and in high quality.
  • Collaborate with Biostatistics and Data Management to ensure effective integration and presentation of clinical data.
Quality and Execution
  • Ensure all documents meet internal and regulatory standards for scientific integrity, clarity, structure, and formatting.
  • Establish and manage quality control and review processes to maintain inspection readiness and document traceability.
  • Implement feedback loops from regulatory interactions and inspections to continuously improve writing processes.
  • Lead lessons-learned efforts post-submission to evolve documentation practices.
  • Directly contribute to cross-functional teams to integrate medical writing activities into overall project plans.

Your profile

  • Advanced degree (PhD, PharmD, MS) in life sciences, health sciences, or a related field.
  • Minimum of 12 years of experience in medical writing within the biotech/pharmaceutical industry, with significant experience leading BLA or NDA submissions.
  • Oncology experience is preferred
  • Proven experience managing end-to-end authorship of regulatory documents in support of late-stage clinical development.
  • Strong understanding of global regulatory requirements, ICH guidelines, and industry standards.
  • Demonstrated leadership in building and managing high-performing teams and external vendors.
  • Excellent written and verbal communication skills with the ability to influence and collaborate cross-functionally.

Our offer

We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to join us as we close in on cancer – everything you do matters at Merus.

Apply now

    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

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