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New · posted Nov 3

Scholar Rock · Biotechnology

Director, Medical Writing

  • Cambridge, MA
  • On-site
  • Full-time
  • Director
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Pay$200K–$250K
EmploymentFull-time
LocationCambridge, MA
LevelDirector
FunctionClinical Evaluation & Medical Writing
DeadlineOpen until filled

The role

Summary of Position

The Director, Medical Writing will be responsible for document development strategies and managing medical writing activities and timelines for clinical and regulatory/health authority drug marketing applications, including US (Investigational New Drug, New Drug Applications, Biologics Licensing Applications) and ex‑US (Clinical Trial Applications, Marketing Authorisation Applications) submissions. This position requires a highly motivated professional with experience in submitting successful drug marketing applications. Key success factors include exceptional leadership skills and scientific writing skills; integrative thinking with a team-centric collaborative mindset; ability to work independently and influence decision-makers; exceptional communication skills; work well under pressure in a fast-paced environment with tight deadlines; and the ability to supervise multiple medical writing projects, contractors, vendors, and budgets.

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

What you need

Candidate Requirements

  • Advanced degree in a relevant scientific field preferred; Bachelor of Science in a relevant scientific field required
  • 10+ years of experience in medical writing within the pharmaceutical/biotech industry, with at least 5+ years at a sponsor company; experience with devices is a plus
  • 5+ years of experience and a proven track record of successful drug application submissions to US (FDA) and ex-US (EMA, MHRA, PMDA) health authorities
  • Extremely strong leadership skills
  • Expert knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory science, and medical terminology
  • Expert knowledge of requirements for the preparation of documents for drug marketing applications and for annual maintenance of clinical development programs (Investigator’s Brochures, Annual Reports, Clinical Study Reports)
  • Ability to work independently in a fast-paced, small biotech corporate environment
  • Ability to be creative and innovative
  • Common sense

    • Skills named in this posting

    What you'll do

  • Create, supervise, and direct complicated document submission plans and teams for marketing applications
  • Collaborate with cross-functional partners to drive development, review, and finalization timelines for submission documents with a sense of urgency to meeting aggressive corporate goals
  • Lead and manage senior-level subject matter experts in the development of complex summary documents (summary and integrated summary documents) for submissions
  • Liaise with senior management to provide transparency on submission activities
  • Manage internal and external resources (contractors, consultants, and vendors) to complete documents for drug applications and submissions
  • Partner with Regulatory and Regulatory Operations to ensure successful submissions
  • Represent Medical Writing on cross-functional teams and workstreams
  • Develop templates, style guidelines, and SOPs related to the Medical Writing function
  • Help build the Medical Writing group to adequately meet the document development needs of SRRK

    • Pay

    $200,000 – $250,000 a year

    Employer provided
    How this compares

    Where you'll work

    Cambridge, MAOn-siteOpen in Maps (opens in a new tab)

    More jobs in Cambridge, MA
    Equal opportunity, accessibility and legal noticesScholar Rock's statements, word for word

    Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

    Job intelligence

    The context around this role

    Live data · November 3, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 5% above the US median for Clinical Evaluation & Medical Writing roles at this level.

    This roleEmployer provided

    $200,000 to $250,000 a year

    Director roles in Massachusetts6 roles publishing pay

    Middle half $195,500 to $225,000, median $211,000

    Director roles in the US13 roles publishing pay

    Middle half $195,000 to $230,000, median $213,500
    Annual base pay
    Annual base payLowMedianHigh
    This role$200,000—$250,000
    Massachusetts$195,500$211,000$225,000
    All US$195,000$213,500$230,000

    This role: Scholar Rock's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Clinical Evaluation & Medical Writing

    The general path across 41 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Scholar Rock's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Clinical Scientist Intern · Medical Writer

      3 open

    2. Earlier

      Senior & Principal

      Often: Senior Medical Writer · Principal Medical Writer

      $140K median19 open

    3. One step back

      Manager

      Often: Manager, Medical Writing, Immunology · Medical Writing Manager

      $150K median5 open

    4. This role

      Director

      Often: Director, Medical Writing · Associate Director, Medical Writing

      $214K median14 open

    Skills DNA

    What this role leans on

    How many of the posting's 5 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    Documentation and SOPs: 3 linesInvestigations and CAPA: 2 linesRegulatory submissions: 3 linesClinical trial conduct: 2 linesCollaboration and leadership: 4 linesDocumentationInvestigationsSubmissionsClinical trialsTeamwork
    • Collaboration and leadership4
    • Documentation and SOPs3
    • Regulatory submissions3
    • Investigations and CAPA2
    • Clinical trial conduct2

    Regulatory intelligence

    The rules behind this role

    Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

    Company hiring pulse

    Scholar Rock on Regulatory Jobs

    7
    Open roles
    7
    Distinct roles
    1
    Locations

    By discipline

    • Clinical4 57%
    • Regulatory2 29%
    • Quality1 14%

    By level

    • Director6 86%
    • VP & Executive1 14%
    See all 7 Scholar Rock roles

    More roles at Scholar Rock

    All 7 Scholar Rock roles

    Similar Clinical Evaluation & Medical Writing roles elsewhere

    Director, Medical Writing at Scholar Rock

    Open until filled. $200K–$250K a year, employer provided.

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