H-1B Visa Associate Director Medical Writing Jobs
Associate Director Medical Writing roles qualify as H-1B visa specialty occupations under the life sciences and clinical regulatory writing category. Employers in pharma, biotech, and CROs regularly sponsor H-1B visas for this title, and cap-exempt research institutions can file outside the annual lottery window.
Find H-1B Visa Associate Director Medical Writing JobsOverview
Showing 5 of 65+ Associate Director Medical Writing jobs
See all 65+ Associate Director Medical Writing Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Associate Director Medical Writing roles.
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 65+ H-1B Visa Associate Director Medical Writing Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Associate Director Medical Writing Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Associate Director Medical Writing
Align your degree to the SOC code
USCIS evaluates specialty occupation based on your degree field matching the role. For Associate Director Medical Writing, a degree in life sciences, pharmacy, or biomedical writing strengthens your petition far more than a general communications credential.
Target cap-exempt employers first
Universities, nonprofit research hospitals, and government-affiliated research organizations can file your H-1B outside the April lottery window. Medical writing roles at academic medical centers often qualify, letting you start without waiting for cap selection.
Search verified H-1B sponsors on Migrate Mate
Filter Associate Director Medical Writing openings by employers with confirmed H-1B LCA filing history. Migrate Mate surfaces DOL Labor Condition Application data so you can focus applications on companies that have sponsored this exact title before.
Request premium processing before your OPT expires
If you're transitioning from OPT, USCIS premium processing cuts the adjudication window to 15 business days. Submit Form I-907 alongside the I-129 so approval lands before your EAD expires and cap-gap protection kicks in.
Benchmark your offer against OFLC Wage Search
Your employer's LCA must certify wages at or above the DOL prevailing wage for your location and job zone. Run the OFLC Wage Search before negotiating so you know the wage floor and can flag any offer that won't clear DOL certification.
Document regulatory writing output as a portfolio
USCIS RFEs for medical writing roles often challenge specialty occupation status. Compile a portfolio of NDA submissions, CSRs, or IND-supporting documents you authored. Evidence of regulated output demonstrates that the role requires specialized degree-level knowledge.
H-1B Visa Associate Director Medical Writing: Frequently Asked Questions
Does Associate Director Medical Writing qualify as an H-1B specialty occupation?
Yes. The role requires theoretical and practical application of life sciences or biomedical writing knowledge, which USCIS recognizes as a specialty occupation. Employers must demonstrate the position normally requires at least a bachelor's degree in a directly related field. Pharma, biotech, and CRO employers routinely file H-1B petitions for this title and are well-practiced in supporting the specialty occupation argument.
Which employers sponsor H-1B visas for medical writing roles at this level?
Large pharmaceutical companies, contract research organizations, and biotech firms are the most active H-1B sponsors for Associate Director Medical Writing. Academic medical centers and nonprofit research hospitals can also sponsor outside the lottery as cap-exempt entities. You can browse employers with verified LCA filing history for this job title on Migrate Mate, which pulls directly from DOL disclosure data.
Can my employer file my H-1B before I finish my OPT period?
Yes, and timing matters. Your employer should file by April 1 so that if you're selected in the lottery, your H-1B status becomes effective October 1. If your OPT expires before October 1, cap-gap protection under USCIS rules automatically extends your work authorization through September 30, provided your employer filed on time and you remain in valid F-1 status.
What documentation does the employer need for the H-1B petition for this role?
The employer files a certified LCA with DOL, then submits Form I-129 to USCIS with supporting evidence. For Associate Director Medical Writing, that evidence typically includes the job description specifying regulatory writing duties, proof the role requires a degree in a relevant field, and your academic credentials. A detailed offer letter referencing ICH E3, FDA, or EMA submission standards reinforces the specialty occupation argument significantly.
Does the Associate Director title create any problems for H-1B sponsorship compared to lower-level medical writing roles?
Director-level titles can attract additional USCIS scrutiny because officers sometimes argue management roles don't require a specific degree. Your employer should document that the position requires hands-on scientific and regulatory writing expertise, not just supervisory duties. Including a breakdown of time spent on writing and review tasks versus management responsibilities in the petition materials directly addresses this concern.