Senior Medical Writer Jobs at Syneos Health with Visa Sponsorship
Syneos Health hires Senior Medical Writers across clinical, regulatory, and publication work, and the company has a track record of sponsoring international talent in scientific writing roles. If you hold a life sciences degree and specialized writing experience, this is a viable path to U.S. employment with visa support.
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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+ Senior Medical Writer at Syneos Health jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Senior Medical Writer at Syneos Health roles.
Get Access To All JobsTips for Finding Senior Medical Writer Jobs at Syneos Health Jobs
Tailor your portfolio to regulatory deliverables
Syneos Health's medical writing teams produce clinical study reports, investigator brochures, and regulatory submissions. Highlight specific document types you've authored, not just therapeutic areas, so hiring managers can immediately assess your fit for active project pipelines.
Target therapeutic areas Syneos actively staffs
Syneos runs large-scale CRO engagements across oncology, CNS, and rare disease. Aligning your application to these areas increases your chances of landing on a team with both open headcount and an established visa sponsorship workflow for scientific staff.
Secure your credentials before the offer stage
For H-1B specialty occupation eligibility, your degree must directly relate to medical writing, typically life sciences, pharmacy, or a clinical field. Get your foreign credential evaluated by a NACES-recognized service before interviews so there are no delays after an offer.
Clarify sponsorship scope during the offer negotiation
Ask HR directly whether their support covers H-1B filing only or extends to Green Card sponsorship through PERM and EB-2 or EB-3. CROs with active international hiring often have both processes in place, but the timeline and employer commitment can vary by role level.
Use Migrate Mate to identify open Senior Medical Writer roles at Syneos Health
Syneos posts Senior Medical Writer openings across multiple business units and regions. Use Migrate Mate to filter for roles that align with your visa type and start tracking positions before they close, which happens quickly for experienced-level scientific writing roles.
Understand F-1 OPT timing relative to H-1B cap deadlines
If you're on STEM OPT, your 24-month extension window must overlap with the April H-1B registration period. Work backwards from your OPT end date and confirm with Syneos HR that they'll initiate registration in time, since missing the cap season means waiting a full year.
Senior Medical Writer at Syneos Health jobs are hiring across the US. Find yours.
Find Senior Medical Writer at Syneos Health JobsFrequently Asked Questions
Does Syneos Health sponsor H-1B visas for Senior Medical Writers?
Yes, Syneos Health sponsors H-1B visas for Senior Medical Writer roles. The position qualifies as a specialty occupation given the degree requirement in a life sciences or clinical field. Your employer files Form I-129 with USCIS on your behalf, and sponsorship typically requires a full-time offer in place before filing begins.
Which visa types are commonly used for Senior Medical Writer roles at Syneos Health?
H-1B is the most common path for international candidates in this role. Syneos also supports F-1 OPT and STEM OPT transitions for recent graduates, as well as TN visas for Canadian and Mexican nationals whose degree and role meet the applicable USMCA occupation categories. Green Card sponsorship through EB-2 or EB-3 is available for qualifying long-term hires.
What qualifications and experience are expected for Senior Medical Writer roles at Syneos Health?
Most Senior Medical Writer postings at Syneos require a degree in a life sciences discipline, pharmacy, or medicine, alongside hands-on experience producing regulatory documents such as clinical study reports or investigator brochures. CRO experience is often preferred. Familiarity with ICH guidelines and therapeutic area depth in oncology, CNS, or rare disease strengthens your candidacy significantly.
How do I apply for Senior Medical Writer jobs at Syneos Health?
You can browse open Senior Medical Writer positions at Syneos Health through Migrate Mate, which filters listings by visa sponsorship eligibility so you can focus on roles that match your status. Applications go through Syneos's careers portal, where you'll submit your resume and often a writing sample. Tailoring your submission to the specific therapeutic area or document type listed in the posting improves your chances of moving to a screening call.
How long does the H-1B sponsorship process take if Syneos Health extends an offer?
The H-1B process runs on an annual cycle. USCIS opens registration in March, conducts a lottery if demand exceeds the cap, and accepts petitions starting April 1 for an October 1 start date. Standard processing takes three to five months after filing. Premium processing, available for an additional USCIS fee, typically returns a decision within 15 business days and is commonly used for time-sensitive start dates.
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