Job Description

Updated: Yesterday Location: USA-HI-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. 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 Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, andIncyte 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 (medical, dental, vision), 401(k) match, 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. Sick time eligibility varies by location. Syneos complies with all applicable paid sick time requirements. Salary Range: $114,000.00 - $210,900.00 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. 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 Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, andIncyte 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. 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, Clinical Study Reports, and marketing authorization submission documents) accurately and consistently present data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents, mentors less experienced writers, and serves as lead writer for individual summary documents. Requires broad understanding of clinical research processes and global regulatory document standards. Reports to a Director of Medical Writing or above. At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage joining our Talent Network to stay connected to additional career opportunities. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting therapies to those who need them. A career with Syneos Health means your everyday work improves patients’ lives around the world. Syneos Health (Nasdaq: SYNH) is a leading 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. 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 to receive assistance. #J-18808-Ljbffr Syneos Health, Inc.

Job Tags

Contract work, Remote work, Flexible hours,

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