Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Director Medical Writing

Biology & BiotechConfirmed live in the last 24 hours

Full-timeCambridge, MA, USA$200k - $250k /yr

About the Job

Requirements

A Bachelor of Science degree in a relevant scientific field is required.
At least 10 years of medical writing experience in the pharmaceutical or biotechnology industry, including at least 5 years at a sponsor company.
At least 5 years of experience and a proven track record of successful drug application submissions to the U.S. Food and Drug Administration and ex-U.S. health authorities, including the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and the Pharmaceuticals and Medical Devices Agency.
Expert knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory science, and medical terminology.
Expert knowledge of requirements for preparing documents for drug marketing applications and annual maintenance of clinical development programs, including Investigator’s Brochures, Annual Reports, and Clinical Study Reports.
Ability to work independently in a fast-paced, small biotechnology corporate environment.
Ability to be creative and innovative.

Responsibilities

Create, supervise, and direct complex document submission plans and teams for marketing applications.
Collaborate with cross-functional partners to drive development, review, and finalization timelines for submission documents in support of corporate goals.
Lead and manage senior-level subject matter experts in developing complex summary and integrated summary documents for submissions.
Liaise with senior management to provide transparency on submission activities.
Manage internal and external resources, including 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 standard operating procedures related to the Medical Writing function.
Help build the Medical Writing group to meet document development needs.

Desired Qualifications

An advanced degree in a relevant scientific field is preferred.
Experience with medical devices is a plus.

Salary Range: 200000 to 250000 (Currency: USD) (Pay period: per-year-salary)

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.

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

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

About the Company

Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Scholar Rock develops biopharmaceutical therapies by targeting protein growth factors to treat diverse diseases. Its work hinges on a proprietary drug discovery platform that identifies ways to modulate these growth factors, enabling creation of novel therapeutic solutions. The company advances its programs through research and development, and collaborates with other biopharmaceutical companies and research institutions, earning revenue via licensing agreements, milestone payments, and eventual product sales. Scholar Rock differentiates itself by focusing on protein growth factors and pursuing targets and indications that have been historically overlooked, with a strong emphasis on partnerships and patient-centric approaches. The overall goal is to deliver safe and effective therapies that improve patient outcomes by precisely modulating growth factor pathways through collaborative science.

Company size: 201-500
Company stage: IPO
Headquarters: Cambridge, MA
Founded: 2012

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