Director Medical Writing Jobs in USA with Visa Sponsorship
Director of Medical Writing roles frequently qualify for H-1B visa and O-1 visa sponsorship, given the advanced scientific and regulatory expertise required. Most positions demand a graduate degree in life sciences or a related field, making specialty occupation classification straightforward for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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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.
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Get Access To All JobsTips for Finding Director Medical Writing Jobs
Lead with your regulatory writing credentials
Employers sponsoring a Director of Medical Writing want evidence of hands-on NDA, BLA, or IND submission experience. Highlight specific regulatory documents you've authored or led to strengthen the specialty occupation argument in your H-1B petition.
Emphasize your advanced degree match
H-1B specialty occupation requires a directly related degree. A master's or PhD in pharmacology, biochemistry, or a clinical field maps cleanly. If your undergraduate degree is in a different discipline, document how graduate coursework bridges the gap.
Target biotech and pharma companies with established immigration programs
Large pharmaceutical companies and mid-size biotechs routinely sponsor senior scientific roles. Employers with dedicated HR immigration teams process petitions faster and with fewer complications than those filing for the first time.
Consider the O-1A if you have a publication or leadership record
Directors with published research, regulatory guidance contributions, or speaking history at major medical conferences may qualify for the O-1A. This visa bypasses the H-1B lottery entirely and is worth discussing with an immigration attorney.
Clarify the managerial versus technical scope of the role
USCIS scrutinizes director-level titles more heavily. Ensure your job offer letter clearly describes the specialized scientific judgment required, not just team oversight. A role defined primarily by technical expertise supports specialty occupation more strongly.
Ask about in-house immigration counsel before accepting an offer
Companies with in-house immigration attorneys or preferred outside counsel process H-1B petitions more reliably. Confirming this before accepting an offer reduces delays and gives you a clearer timeline from petition filing to start date.
Frequently Asked Questions
Does Director of Medical Writing qualify as a specialty occupation for H-1B purposes?
Yes. Director of Medical Writing consistently qualifies as an H-1B visa specialty occupation because the role requires a bachelor's degree or higher in a specific scientific or technical field, such as pharmacology, biochemistry, or life sciences. USCIS expects a direct relationship between the degree field and the regulatory, clinical, and scientific writing tasks the role demands. Director-level positions with significant managerial duties should include a detailed job description emphasizing the specialized knowledge required.
What degree do I need to get H-1B sponsorship as a Director of Medical Writing?
Most employers require at least a bachelor's degree in a life science, pharmacy, or health-related field, and many prefer a master's or PhD. The degree must relate specifically to the work, not just to writing in general. A degree in English or communications alone is unlikely to support an H-1B petition for this role. If your undergraduate degree is in a different field, a graduate degree in pharmacology, clinical research, or regulatory affairs typically resolves the specialty occupation requirement.
Are Director of Medical Writing jobs commonly sponsoring visas in 2025?
Yes. Pharmaceutical companies, contract research organizations, and biotechs regularly sponsor senior medical writing roles because qualified candidates are scarce and the regulatory expertise required is highly specialized. You can browse currently available sponsored Director of Medical Writing positions on Migrate Mate, which filters specifically for roles open to visa sponsorship so you're not wasting applications on companies that won't file.
Can I qualify for an O-1A visa as a Director of Medical Writing?
Possibly, depending on your record. The O-1A requires extraordinary ability demonstrated through peer-reviewed publications, regulatory guidance contributions, judging others' work, or critical roles at distinguished organizations. Senior medical writers who have authored widely cited clinical study reports, contributed to FDA guidance documents, or held leadership roles in organizations like AMWA or DIA may meet the threshold. An immigration attorney can assess whether your profile clears the bar before you pursue this path.
How does the H-1B lottery affect my chances of getting sponsored as a Director of Medical Writing?
The standard H-1B lottery applies unless your employer qualifies as a cap-exempt institution, such as a university medical center or nonprofit research organization. In FY 2025, USCIS received roughly 442,000 registrations for 85,000 available slots, producing a selection rate around 25%. If you're not selected, options include reapplying the following year, exploring cap-exempt employers, or assessing O-1A eligibility. Some employers will also explore the TN visa for Canadian or Mexican nationals with qualifying credentials.
What is the prevailing wage requirement for sponsored Director Medical Writing jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.