Medical Writer Jobs at Syneos Health with Visa Sponsorship
Syneos Health hires Medical Writers across clinical, regulatory, and publications functions, with roles spanning contract research and biopharmaceutical services. The company has a documented track record of sponsoring work visas for scientific and research professionals, making it a realistic target if you're building a U.S. career in medical writing.
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Senior Medical Writer - CSR and Protocol
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
- Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
- Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; 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.
- Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
- Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed.
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
- Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
- Performs online clinical literature searches and complies with copyright requirements.
- Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
- Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
- Completes required administrative tasks within the specified timeframes.
- Performs other work-related duties as assigned.
- Minimal travel may be required (less than 25%).
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
$80,600.00 - $145,000.00
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
We are looking for a Senior Medical Writer with strong expertise in late Phase Protocol and CSR writing. Experience with authoring of additional documents such as NDA, IND, IB, DSUR, RMP, Briefing Package and Response documents amongst others is also taken into consideration.
Description
Senior Medical Writer - CSR and Protocol
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
- Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
- Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; 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.
- Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
- Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed.
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
- Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
- Performs online clinical literature searches and complies with copyright requirements.
- Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
- Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
- Completes required administrative tasks within the specified timeframes.
- Performs other work-related duties as assigned.
- Minimal travel may be required (less than 25%).
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
$80,600.00 - $145,000.00
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
We are looking for a Senior Medical Writer with strong expertise in late Phase Protocol and CSR writing. Experience with authoring of additional documents such as NDA, IND, IB, DSUR, RMP, Briefing Package and Response documents amongst others is also taken into consideration.
See all 72+ Medical Writer at Syneos Health jobs
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Get Access To All JobsTips for Finding Medical Writer Jobs at Syneos Health Jobs
Frame your credentials around regulatory writing standards
Syneos Health's Medical Writer roles often support IND, NDA, and BLA submissions. Tailor your CV to highlight experience with FDA-regulated documents, such as clinical study reports, protocols, and investigator brochures, rather than general scientific writing.
Target roles tied to active therapeutic programs
Syneos Health staffs Medical Writers to specific sponsor projects. Roles aligned with oncology or rare disease programs tend to have longer engagement windows, which strengthens the employer's business case for filing an H-1B petition rather than hiring short-term contract staff.
Clarify sponsorship scope before the offer stage
Ask the recruiter directly whether the role is eligible for H-1B sponsorship and whether it falls under a client-embedded or internal headcount model. CRO structures mean some positions are billed to pharmaceutical clients, which can affect who files the petition.
Align your degree field with specialty occupation requirements
USCIS evaluates H-1B Medical Writer petitions on whether the degree field directly relates to the role. A degree in life sciences, pharmacy, or biomedical writing is a stronger fit than a general communications degree when supporting regulatory submissions.
Use Migrate Mate to filter open Medical Writer positions at Syneos Health
Syneos Health frequently posts Medical Writer roles across multiple therapeutic areas and contract types. Search Migrate Mate to browse current openings filtered by sponsorship eligibility, so you're only applying to positions where visa support is confirmed available.
Time your application around PERM and H-1B filing windows
If you're aiming for permanent residence through EB-2 or EB-3, your employer must begin PERM labor certification before your H-1B clock limits your options. Ask HR about their standard timeline for initiating green card sponsorship after your first year.
Medical Writer at Syneos Health jobs are hiring across the US. Find yours.
Find Medical Writer at Syneos Health JobsFrequently Asked Questions
Does Syneos Health sponsor H-1B visas for Medical Writers?
Yes, Syneos Health has a documented history of sponsoring H-1B visas for Medical Writers. Because the company operates as a contract research organization, sponsorship decisions can depend on whether the role sits on internal headcount or is tied to a specific client project. Confirming this distinction with the recruiter early in the process helps you understand who will be the petitioner of record.
Which visa types are commonly used for Medical Writer roles at Syneos Health?
H-1B is the most common nonimmigrant visa for Medical Writers at Syneos Health, given the specialty occupation requirements the role satisfies under USCIS guidelines. F-1 OPT is also used by recent graduates in life sciences or pharmacy programs. TN classification is available for Canadian and Mexican nationals in qualifying scientific roles. For longer-term pathways, Syneos Health has supported EB-2 and EB-3 Green Card sponsorship for Medical Writers.
What qualifications does Syneos Health expect for Medical Writer roles?
Most Medical Writer positions at Syneos Health require a bachelor's degree or higher in a life sciences field such as biology, pharmacology, biochemistry, or a health-related discipline. Regulatory writing experience, specifically with clinical study reports, protocols, or submissions to the FDA or EMA, is frequently listed as a requirement. Familiarity with ICH guidelines and experience within a CRO or pharmaceutical environment strengthens your application considerably.
How do I apply for Medical Writer jobs at Syneos Health?
Browse open Medical Writer positions at Syneos Health through Migrate Mate, where listings are filtered to show roles with confirmed visa sponsorship availability. Once you identify a suitable role, apply directly through Syneos Health's careers portal. In your cover letter, address your regulatory writing background and specify your visa status upfront so the recruiter can assess sponsorship eligibility without delay.
How do I plan my timeline if I need H-1B sponsorship at Syneos Health?
The H-1B cap registration window opens each March, with an October 1 start date for selected petitions. If you're on F-1 OPT, your program end date determines how urgently you need a sponsor to file. Starting conversations with Syneos Health recruiters at least four to six months before your authorization expires gives the company adequate time to prepare the petition and file the Labor Condition Application with the DOL before registration opens.
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