Principal Medical Writer – Regulatory

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Lead the clear and accurate completion of medical writing deliverables and coordinate medical writing activities across departments. • Lead resolution of client comments. • Complete clinical and regulatory documents, including protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations. • Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides. • Coordinate quality and editorial reviews; manage source documentation appropriately. • Lead team document reviews and act as a peer reviewer. • Review statistical analysis plans and table/figure/listing specifications, providing feedback on statistical outputs and document needs. • Build working relationships with clients and data management, biostatistics, regulatory affairs, and medical affairs teams. • Perform online clinical literature searches and comply with copyright requirements. • Identify and propose solutions to issues, escalating as appropriate. • Provide technical support, training, and consultation to staff. • Mentor and lead less experienced medical writers on complex projects. • Develop expertise in industry topics and regulatory requirements affecting medical writing. • Monitor assigned project budgets and communicate status or changes to medical writing leadership. • Complete required administrative tasks and other assigned duties.

🎯 Requirements

• Experience, skills, and/or education equivalent to the qualifications determined by the company may be considered. • Adherence to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides. • Ability to review statistical analysis plans and table/figure/listing specifications. • Ability to perform online clinical literature searches and comply with copyright requirements. • Ability to work within budgeted hours and communicate project status and changes. • Ability to provide technical support, training, and consultation. • Ability to mentor and lead less experienced medical writers on complex projects. • Ability to develop expertise in regulatory requirements and guidelines affecting medical writing. • Minimal travel may be required (less than 25%).

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Minimal travel may be required (less than 25%)