Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. technical and therapeutic area training; The 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. Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other integral guidelines, standards and processes, and the client 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 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. Bachelor's degree required. At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.

Strong organizational, time management, and project management skills are required. Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired. Further, nothing contained herein should be construed to create an employment contract.

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. Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create... #

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