Job Description

Overview Updated: September 16, 2025 Location: USA-AZ-Remote Job ID: 25101798 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. 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 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 communication 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 process(es) 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 an 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. Salary Range $114,000.00 - $210,900.00 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. Description Senior Principal Medical Writer 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. 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 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 communication 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 process(es) 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 an 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. 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. Benefits include company car or car allowance, health benefits (Medical, Dental, Vision), 401k match, Employee Stock Purchase Plan, performance bonuses, and flexible PTO/sick time. Sick time eligibility varies by location; Syneos complies with all applicable paid sick time requirements. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes equivalent qualifications. Nothing herein should be construed as a contract. The Company is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations when appropriate. Summary The Associate Director, Principal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (e.g., Investigators\' Brochures, CSRs, and regulatory documents) accurately present data-driven clinical messages. Writes or directs other writers to ensure timely delivery of high-quality documents that are scientifically rigorous and well-structured. Oversees medical writing activities of multiple compounds and mentors less experienced writers. Reports to a Director of Medical Writing or above. Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart to bring therapies to patients. Syneos Health is an Equal Opportunity Employer. Contact: Email: jobs@syneoshealth.com #J-18808-Ljbffr Syneos Health, Inc.

Job Tags

Similar Jobs