Principal Medical Writer – Regulatory Focus

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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 accurately and consistently present key data-driven clinical messages. • 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. • Manage medical writing projects, including developing timelines and communication with cross-functional team members to maintain awareness of review cycles and expectations. • Review other documents associated with the assigned project(s) as appropriate. • Participate in cross-functional process improvement initiatives.

🎯 Requirements

• Bachelor's degree required. • Advanced degree in a relevant scientific/clinical/regulatory field preferred. • At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development. • Proficiency in organizing and communicating clinical information required with minimal oversight. • Strong organizational, time management, and project management skills are required. • Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment. • Proficient understanding and knowledge of global regulatory requirements needed.

🏖️ Benefits

• 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 building an inclusive culture – where you can authentically be yourself.