Principal Medical Writer Jobs in USA with Visa Sponsorship
Principal Medical Writers in the U.S. typically qualify for H-1B or O-1 visa sponsorship, as the role meets specialty occupation requirements through its demand for a life sciences or pharmacy degree. Employers in pharma, biotech, and CROs sponsor regularly. For detailed occupation requirements, see the O*NET profile.
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Principal Medical Writer - Regulatory Submission Documents
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
- Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
- Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
- Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
- Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
- Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
- Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
- Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
- Mentor and lead less experienced medical writers on complex projects
- Develop deep expertise on key topics in the industry and regulatory requirements
- Work within budget specifications for assigned projects
Qualifications
- Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Necessary Skills:
- Strong presentation, proofreading, collaborative, and interpersonal skills
- Strong project and time management skills
- Strong proficiency in MS Office
- Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$95,000.00 - $175,700.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility.
Impact and Contribution
Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.
Core Focus
- Leading the clear and accurate completion of medical writing deliverables
- Managing medical writing activities associated with individual studies
- Coordinating these activities within and across departments
- Completing a variety of documents, adhering to established regulatory standards
- Coordinating quality and editorial reviews
- Acting as peer reviewers for the internal team
- Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency
- Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs
- Performing online clinical literature searches and complying with copyright requirements
- Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
- Mentoring and leading less experienced medical writers on complex projects
- Developing deep expertise on key topics in the industry and regulatory requirements
- Working within budget specifications for assigned projects
Description
Principal Medical Writer - Regulatory Submission Documents
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
- Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
- Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
- Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
- Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
- Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
- Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
- Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
- Mentor and lead less experienced medical writers on complex projects
- Develop deep expertise on key topics in the industry and regulatory requirements
- Work within budget specifications for assigned projects
Qualifications
- Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Necessary Skills:
- Strong presentation, proofreading, collaborative, and interpersonal skills
- Strong project and time management skills
- Strong proficiency in MS Office
- Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$95,000.00 - $175,700.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility.
Impact and Contribution
Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.
Core Focus
- Leading the clear and accurate completion of medical writing deliverables
- Managing medical writing activities associated with individual studies
- Coordinating these activities within and across departments
- Completing a variety of documents, adhering to established regulatory standards
- Coordinating quality and editorial reviews
- Acting as peer reviewers for the internal team
- Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency
- Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs
- Performing online clinical literature searches and complying with copyright requirements
- Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
- Mentoring and leading less experienced medical writers on complex projects
- Developing deep expertise on key topics in the industry and regulatory requirements
- Working within budget specifications for assigned projects
How to Get Visa Sponsorship as a Principal Medical Writer
Target CROs and large pharma companies first
Contract research organizations and established pharmaceutical companies like Pfizer, Merck, and ICON have dedicated immigration teams and sponsor Principal Medical Writers routinely. They're far more likely to have an established H-1B sponsorship process than smaller startups.
Confirm your degree field aligns with the role
USCIS expects a direct connection between your degree and the job. A background in pharmacy, medicine, life sciences, or biomedical sciences strongly supports a specialty occupation finding for Principal Medical Writer roles. Unrelated degrees create petition risk.
Emphasize regulatory writing experience in applications
Employers sponsoring at the Principal level need to justify the hire to USCIS. Regulatory submissions experience, clinical study reports, INDs, NDAs, CTDs, signals the specialized expertise that strengthens both your candidacy and the sponsorship case.
Ask about sponsorship before the final interview stage
Raise visa sponsorship after initial interest is confirmed but before final rounds. Framing it as a process question rather than a demand gives the hiring team space to check with HR without creating friction during early screening conversations.
O-1A is worth considering if you have strong credentials
Principal Medical Writers with published research, regulatory submission credits, or industry awards may qualify for O-1A extraordinary ability status. Unlike H-1B, there's no lottery, making it a reliable alternative for senior candidates with a documented track record.
Document your contribution to regulatory submissions carefully
When employers assess sponsorship feasibility, they review your resume for evidence of specialized work. Listing specific submission types, therapeutic areas, and lead-author contributions gives immigration counsel the material needed to build a defensible H-1B petition.
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Get Access To All JobsFrequently Asked Questions
Do Principal Medical Writer roles qualify for H-1B sponsorship?
Yes. Principal Medical Writer is widely recognized as a specialty occupation because the position normally requires at least a bachelor's degree in a specific life sciences field, pharmacy, biology, medicine, or a related discipline. USCIS approvals for medical writing roles are common, particularly when the employer documents the degree requirement in the Labor Condition Application and job description.
Which visa types do employers typically sponsor for this role?
H-1B is the most common path. Employers in pharma and CROs file H-1B petitions regularly for Principal Medical Writers. O-1A is a viable alternative for candidates with strong publication records, regulatory submission credits, or industry recognition, since it bypasses the lottery. TN status can apply for Canadian and Mexican nationals if the role maps to an eligible USMCA occupation category.
What degree does USCIS expect for a Principal Medical Writer petition?
USCIS typically expects a bachelor's degree or higher in a field directly related to the job, pharmacy, medicine, life sciences, nursing, or biomedical sciences are the strongest fits. A degree in a loosely related field can still work if the employer provides additional evidence, such as industry standards documentation showing degree requirements for the position. Unrelated degrees significantly complicate the petition.
How likely is an H-1B petition to be approved for this job title?
Approval rates for H-1B petitions in medical writing are generally strong when filed by experienced employers with well-documented job descriptions. The specialty occupation question is usually straightforward for Principal-level roles, where the degree requirement is clear and the work is technical. Petitions run into trouble when job descriptions are vague or when the employer lacks prior sponsorship experience. Working with an immigration attorney improves outcomes meaningfully.
Where can I find Principal Medical Writer jobs that offer visa sponsorship?
Migrate Mate is built specifically for international candidates seeking U.S. roles with visa sponsorship. You can browse Principal Medical Writer openings filtered by employers with active sponsorship histories, which removes the guesswork of cold-applying to companies unlikely to sponsor. Most general job boards don't surface sponsorship data, so candidates waste time on roles that will never move forward.
What is the prevailing wage requirement for sponsored Principal Medical Writer 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.
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