Senior Medical Writer – Regulatory Documents

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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 • Manage medical writing activities associated with individual studies and coordinate activities across departments • Lead resolution of client comments • Complete clinical and regulatory documents, including protocols, clinical study reports, patient narratives, investigator brochures, informed consents, safety reports, clinical development plans, IND submissions, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations • Apply regulatory standards, company procedures, client standards, templates, authorship requirements, and style guides • Coordinate quality and editorial reviews • Manage source documentation appropriately • Lead team document reviews and perform peer reviews • Review statistical analysis plans and table/figure/listing specifications • Collaborate 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 • Contribute to internal materials, presentations, processes, standards, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements affecting medical writing • Monitor project budgets and communicate status or changes to medical writing leadership • Complete administrative tasks and other assigned duties

🎯 Requirements

• Leads medical writing deliverables with clear and accurate scientific content • Ability to manage medical writing activities across individual studies and departments with minimal supervision • Knowledge of regulatory standards, including ICH E3 guidelines • Ability to work with company and client SOPs, standards, templates, authorship requirements, and style guides • Experience reviewing statistical analysis plans and table/figure/listing specifications • Ability to conduct online clinical literature searches and comply with copyright requirements • Ability to collaborate with clients and cross-functional teams • Ability to provide technical support, training, and consultation • Ability to mentor and lead less experienced medical writers on complex projects • Ability to manage project budgets and communicate status and changes • Equivalent experience, skills, and/or education will also be considered • 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%)