Syneos Health, Inc.
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor
Updated:
October 2, 2025 Location:
USA-AL-Remote Job ID:
25101798
Description
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 centers customers and patients; we continuously simplify and streamline our work to make Syneos Health easier to work with and 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 about changing lives.
Job Responsibilities
Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical‑writing projects, including developing timelines (working with the study/project teams, as necessary) and communicating with cross‑functional team members to maintain awareness of review cycles and expectations.
Participate in cross‑functional meetings to provide input regarding medical‑writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
Participate in cross‑functional process‑improvement initiatives.
Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents.
Manage internal and contract medical‑writing resources as required to ensure timely completion of assigned projects.
Mentor more junior medical‑writing staff.
Benefits
Company car or car allowance, health benefits (medical, dental, vision), company match 401k, participation in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on performance, and flexible 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
$114,000.00 - $210,900.00
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.
Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com One of our staff members will work with you to provide alternate means to submit your application.
#J-18808-Ljbffr
October 2, 2025 Location:
USA-AL-Remote Job ID:
25101798
Description
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 centers customers and patients; we continuously simplify and streamline our work to make Syneos Health easier to work with and 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 about changing lives.
Job Responsibilities
Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical‑writing projects, including developing timelines (working with the study/project teams, as necessary) and communicating with cross‑functional team members to maintain awareness of review cycles and expectations.
Participate in cross‑functional meetings to provide input regarding medical‑writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
Participate in cross‑functional process‑improvement initiatives.
Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents.
Manage internal and contract medical‑writing resources as required to ensure timely completion of assigned projects.
Mentor more junior medical‑writing staff.
Benefits
Company car or car allowance, health benefits (medical, dental, vision), company match 401k, participation in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on performance, and flexible 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
$114,000.00 - $210,900.00
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.
Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: jobs@syneoshealth.com One of our staff members will work with you to provide alternate means to submit your application.
#J-18808-Ljbffr