Advanced degree in a relevant scientific field preferred; Bachelor of Science required
10+ years of medical writing experience in the pharmaceutical/biotech industry
5+ years of successful drug application submissions to US and ex-US health authorities
Extremely strong leadership skills
Expert knowledge of biologics drug development and regulatory science
Ability to work independently in a fast-paced environment
Creative and innovative problem-solving skills
Responsibilities
Create and direct complex document submission plans for marketing applications
Collaborate with cross-functional partners to meet aggressive submission timelines
Lead senior-level experts in developing complex summary documents
Liaise with senior management for transparency on submission activities
Manage internal and external resources for drug application documents
Partner with Regulatory teams to ensure successful submissions
Represent Medical Writing on cross-functional teams
Develop templates and SOPs for the Medical Writing function
Help build the Medical Writing group to meet document development needs
Benefits
Comprehensive health insurance
Retirement savings plan
Flexible work arrangements
Professional development opportunities
Collaborative work environment
Full Job Description
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.
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
$200,000 - $250,000 a year
About Scholar Rock Holding Corporation
Scholar Rock Holding Corporation is a clinical-stage biopharmaceutical company that focuses on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. The company's proprietary platform technology is based on the use of growth factor-binding proteins to selectively inhibit the activation of these signaling pathways in a variety of tissues. Scholar Rock's lead product candidate, SRK-015, is a highly specific inhibitor of the activation of the growth factor myostatin, which is involved in the regulation of muscle mass. The company is headquartered in Cambridge, Massachusetts and was founded in 2012.
