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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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Summary
To coordinate and author complex regulatory documents needed for regulatory submissions ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members for assets in the immunology and cardiovascular therapeutic areas. Implements regulatory documentation standards that support speed and consistency of regulatory submissions across all full development / life cycle management assets and geographies.
Key Responsibilities
- Author complex clinical documents needed for regulatory submissions (eg, Pivotal Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA Briefing Books, responses to Health Authority queries) for timely submission to health authorities worldwide according to:
- good documentation principles (organization, clarity, scientific standards)
- consistency between text and tabular presentations or graphical displays
- in compliance with BMS documentation standards and regulatory requirements
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
- Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
- Prepare document prototypes, including the document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. Lead or co-lead (with Documentation Lead) teams to define content and organization for complex documents (eg CTD summary documents).
- Comply with internal processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure:
- optimal communication between authoring team and development team members
- coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
- timely completion and high quality of assigned documents
- Review regulatory and clinical documentation according to good documentation practices (organization, clarity, scientific standards), to establish consistency of content within TA and asset, and compliance with BMS documentation standards and worldwide regulatory requirements.
- Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
- Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.
Qualifications & Experience
- PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
- Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans).
- Analyze and interpret complex data from a broad range of scientific disciplines.
- Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions.
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Working knowledge of a document management system and basic knowledge of the document publishing process.
- Experience in the areas of state-of-the-art documentation processes and technology.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Princeton - NJ - US: $170,880 - $207,061
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1604781 : EG-140 - Regulatory Affairs / Medical Writing
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Position Summary
To coordinate and author complex regulatory documents needed for regulatory submissions ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members for assets in the immunology and cardiovascular therapeutic areas. Implements regulatory documentation standards that support speed and consistency of regulatory submissions across all full development / life cycle management assets and geographies.
Key Responsibilities
- Author complex clinical documents needed for regulatory submissions (eg, Pivotal Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA Briefing Books, responses to Health Authority queries) for timely submission to health authorities worldwide according to:
- good documentation principles (organization, clarity, scientific standards)
- consistency between text and tabular presentations or graphical displays
- in compliance with BMS documentation standards and regulatory requirements
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
- Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
- Prepare document prototypes, including the document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. Lead or co-lead (with Documentation Lead) teams to define content and organization for complex documents (eg CTD summary documents).
- Comply with internal processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure:
- optimal communication between authoring team and development team members
- coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
- timely completion and high quality of assigned documents
- Review regulatory and clinical documentation according to good documentation practices (organization, clarity, scientific standards), to establish consistency of content within TA and asset, and compliance with BMS documentation standards and worldwide regulatory requirements.
- Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.
- Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.
Qualifications & Experience
- PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
- Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans).
- Analyze and interpret complex data from a broad range of scientific disciplines.
- Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions.
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Working knowledge of a document management system and basic knowledge of the document publishing process.
- Experience in the areas of state-of-the-art documentation processes and technology.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Princeton - NJ - US: $170,880 - $207,061
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1604781 : EG-140 - Regulatory Affairs / Medical Writing
See all 77+ H-1B Visa Director Medical Writing Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Director Medical Writing Jobs.
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.