H-1B Visa Director Medical Writing Jobs
Director Medical Writing roles qualify as H-1B visa specialty occupations, requiring at least a bachelor's degree in a life sciences or related field. Large pharmaceutical, biotech, and CRO employers regularly sponsor H-1B petitions for this title, and the role's regulatory documentation requirements make it a strong fit for prevailing wage Level III or IV classifications.
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Get Access To All JobsLocation: Cambridge, MA
Job Type: Full-Time
Work Arrangement: On-site
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
Compensation:
- Salary Range: $200,000 - $250,000 a year
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Location: Cambridge, MA
Job Type: Full-Time
Work Arrangement: On-site
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
Compensation:
- Salary Range: $200,000 - $250,000 a year
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
See all H-1B Visa Director Medical Writing Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Director Medical Writing
Align your credentials to specialty occupation standards
Your degree must directly relate to medical writing, not just science broadly. A degree in pharmacy, biochemistry, or regulatory affairs strengthens the specialty occupation argument more than a general biology degree paired with work experience alone.
Target pharmaceutical and CRO employers with H-1B history
Use Migrate Mate to filter Director Medical Writing roles by employers who have filed H-1B Labor Condition Applications for this job title, so you're only pursuing companies with a demonstrated sponsorship track record.
Verify prevailing wage level before accepting an offer
Run the OFLC Wage Search using the SOC code for Medical Scientists or Technical Writers before negotiating. Directors typically fall at Level III or IV, and an offer below that threshold forces the employer to revise the LCA before filing.
Check whether your employer qualifies as H-1B dependent
Employers with a high ratio of H-1B workers to total staff face stricter attestation requirements under the H-1B dependent employer rules. Ask HR directly during the offer stage, as this affects your petition timeline and the employer's obligations to recruit U.S. workers first.
Secure an O*NET classification review for your job description
Director Medical Writing doesn't map to a single O*NET code, so your employer's LCA may reference Medical Scientists or Technical Writers. Request a copy of the job description used for the LCA and confirm the duties match your actual role to avoid an RFE on specialty occupation grounds.
Plan around the October 1 start date when changing employers
If you're transferring an H-1B to a new employer mid-year, portability under AC21 lets you start work once the transfer petition is filed, not approved. Confirm your new employer files before your current authorized period ends so you don't create a gap in status.
H-1B Visa Director Medical Writing: Frequently Asked Questions
Does a Director Medical Writing role qualify as an H-1B specialty occupation?
Yes. USCIS evaluates specialty occupation status based on whether the role normally requires at least a bachelor's degree in a specific field. Director Medical Writing meets this standard because the position requires specialized knowledge in regulatory science, clinical data interpretation, or a related life sciences discipline. Your employer will document this in the I-129 petition using the job description and industry norms.
Which employers sponsor H-1B visas for Director Medical Writing positions?
Pharmaceutical companies, contract research organizations, and biotech firms are the most consistent H-1B sponsors for this title. You can browse Director Medical Writing roles filtered by verified LCA filing history on Migrate Mate, which pulls directly from DOL disclosure data so you're targeting employers who have already sponsored this job category.
How does prevailing wage apply to a Director-level medical writing role?
The DOL requires H-1B employers to pay at least the prevailing wage for the occupation and geographic location listed on the LCA. At Director level, most petitions are certified at wage Level III or Level IV under the OFLC Wage Search system. Your employer must meet or exceed that threshold from your first day in H-1B status, not just at hire.
Can I change employers if my H-1B is already approved for a medical writing role?
Yes, through H-1B portability under AC21, you can transfer to a new employer in a same or similar occupational classification once your new employer files an H-1B transfer petition. For Director Medical Writing, same or similar generally means the new role involves comparable regulatory or scientific writing responsibilities. You can start working for the new employer as soon as the transfer petition is received by USCIS.
Does the H-1B cap apply to Director Medical Writing positions?
Most private-sector medical writing positions are subject to the annual H-1B cap and lottery, which covers 85,000 new H-1B visas per fiscal year. Cap-exempt status applies only if your employer is a nonprofit research institution, university, or affiliated entity. Standard pharmaceutical and CRO employers are cap-subject, so timing your job search around the annual registration period each March is essential.