Syneos Health, Inc.
Principal/Sr Medical Writer (Regulatory & Publications)
Syneos Health, Inc., Jackson, Mississippi, United States
Principal/Sr Medical Writer (Regulatory & Publications)
Updated:
Yesterday
Location:
USA-MS-Remote
Job ID:
25103001
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 places the customer and the patient at the center of everything we do, simplifying and streamlining our work to be both easier to work with and 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, innovate as a team, and help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.
Why Syneos Health
We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself.
We continuously build the company we want to work for and our customers want to work with, fostering a place where everyone feels they belong.
Job Responsibilities
Lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities associated with individual studies, define document strategy, and coordinate activities within and across departments with minimal supervision. Lead the resolution of client comments.
Complete a variety of documents, including clinical study protocols and amendments, clinical study 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 (e.g., ICH E3 guidelines) and company SOPs, client standards, approved templates, authorship requirements, and style guides on time and within budget.
Advise clients and study teams on data presentation and production strategies to meet client objectives while maintaining quality standards.
Lead team document reviews, review documents for technical issues, coordinate quality and editorial reviews, and ensure source documentation is managed appropriately.
Serve as an expert peer reviewer, providing comments that maximize clarity, accuracy, and relevance, ensuring client objectives are met.
Review statistical analysis plans and table/figure/specification documents for content, grammar, format, and consistency; provide feedback to define required statistical outputs and document needs.
Interact and build working relationships with clients and cross‑functional teams in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables and advance company priorities.
Perform online clinical literature searches while complying with copyright requirements.
Identify and propose solutions to resolve issues, escalating as appropriate; serve as a key technical SME and contribute to internal materials and presentations.
Mentor and lead less experienced medical writers on complex documents.
Develop deep expertise on key industry topics and regulatory requirements that affect medical writing; engage externally with industry groups on initiatives.
Maintain awareness of budget specifications for assigned projects, communicate status and changes to leadership, and contribute to bid projections.
Represent the medical writing department on clinical study teams, at conferences, meetings, and for client presentations regarding writing projects.
Complete required administrative tasks within specified timeframes.
Perform other related duties as assigned.
Travel may be required (less than 25%).
We are excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role; by expressing your interest, you'll be added to our talent pipeline and considered should the role become available.
At Syneos Health, we provide an environment where people can thrive, develop, and advance. In addition to a competitive salary, benefits may include a company car or car allowance, health benefits (medical, dental and vision), a company‑match 401(k), eligibility to participate in an Employee Stock Purchase Plan, commissions/bonuses tied to performance, and flexible paid time off (PTO) and sick time. Payable sick time may vary by location in accordance with applicable regulations.
Salary Range: This range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies and proficiency.
Summary Principal medical writer on clinical study or regulatory project teams. Provides scientific writing, regulatory guidance, and technical expertise in the writing, production, and review of high‑quality complex regulatory and other scientific/clinical documents, ensuring compliance with applicable regulatory guidelines.
Discover what our 29,000 employees already know: work here matters everywhere. A career with Syneos Health improves patients’ lives around the world. We support a diverse, equitable and inclusive culture.
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.
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 education may also be considered. The Company will determine what constitutes equivalence to the qualifications described above. Requirements are intended to comply with the legislation of each country in which it operates, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when appropriate.
Get to Know Syneos Health Over the past five 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.
Learn more about Syneos Health at
www.syneoshealth.com .
#J-18808-Ljbffr
Yesterday
Location:
USA-MS-Remote
Job ID:
25103001
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 places the customer and the patient at the center of everything we do, simplifying and streamlining our work to be both easier to work with and 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, innovate as a team, and help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.
Why Syneos Health
We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself.
We continuously build the company we want to work for and our customers want to work with, fostering a place where everyone feels they belong.
Job Responsibilities
Lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities associated with individual studies, define document strategy, and coordinate activities within and across departments with minimal supervision. Lead the resolution of client comments.
Complete a variety of documents, including clinical study protocols and amendments, clinical study 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 (e.g., ICH E3 guidelines) and company SOPs, client standards, approved templates, authorship requirements, and style guides on time and within budget.
Advise clients and study teams on data presentation and production strategies to meet client objectives while maintaining quality standards.
Lead team document reviews, review documents for technical issues, coordinate quality and editorial reviews, and ensure source documentation is managed appropriately.
Serve as an expert peer reviewer, providing comments that maximize clarity, accuracy, and relevance, ensuring client objectives are met.
Review statistical analysis plans and table/figure/specification documents for content, grammar, format, and consistency; provide feedback to define required statistical outputs and document needs.
Interact and build working relationships with clients and cross‑functional teams in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables and advance company priorities.
Perform online clinical literature searches while complying with copyright requirements.
Identify and propose solutions to resolve issues, escalating as appropriate; serve as a key technical SME and contribute to internal materials and presentations.
Mentor and lead less experienced medical writers on complex documents.
Develop deep expertise on key industry topics and regulatory requirements that affect medical writing; engage externally with industry groups on initiatives.
Maintain awareness of budget specifications for assigned projects, communicate status and changes to leadership, and contribute to bid projections.
Represent the medical writing department on clinical study teams, at conferences, meetings, and for client presentations regarding writing projects.
Complete required administrative tasks within specified timeframes.
Perform other related duties as assigned.
Travel may be required (less than 25%).
We are excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role; by expressing your interest, you'll be added to our talent pipeline and considered should the role become available.
At Syneos Health, we provide an environment where people can thrive, develop, and advance. In addition to a competitive salary, benefits may include a company car or car allowance, health benefits (medical, dental and vision), a company‑match 401(k), eligibility to participate in an Employee Stock Purchase Plan, commissions/bonuses tied to performance, and flexible paid time off (PTO) and sick time. Payable sick time may vary by location in accordance with applicable regulations.
Salary Range: This range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies and proficiency.
Summary Principal medical writer on clinical study or regulatory project teams. Provides scientific writing, regulatory guidance, and technical expertise in the writing, production, and review of high‑quality complex regulatory and other scientific/clinical documents, ensuring compliance with applicable regulatory guidelines.
Discover what our 29,000 employees already know: work here matters everywhere. A career with Syneos Health improves patients’ lives around the world. We support a diverse, equitable and inclusive culture.
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.
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 education may also be considered. The Company will determine what constitutes equivalence to the qualifications described above. Requirements are intended to comply with the legislation of each country in which it operates, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when appropriate.
Get to Know Syneos Health Over the past five 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.
Learn more about Syneos Health at
www.syneoshealth.com .
#J-18808-Ljbffr