Senior Medical Writer - Regulatory Writing

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor
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. 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.

technical and therapeutic area training; We are continuously building the company we all want to work for and our customers want to work with. 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.

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) (eg, 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.

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. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

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.

Further, nothing contained herein should be construed to create an employment contract. 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.
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 (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key 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 that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards. Reports to a Director of Medical Writing or above.