The Medical Writing Projects Director 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.

Position Responsibilities:

• • 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

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

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