Senior MW/PMW, clinical document writing

🔥 6 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $80.6k - $175.7k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

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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, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations • Apply ICH E3 guidelines, company procedures, client standards, templates, authorship requirements, and style 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, and 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, standard practices, and capabilities • 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 and changes to medical writing leadership • Complete administrative tasks and other assigned duties

🎯 Requirements

• Proven strong clinical document writing experience • Ability to lead medical writing deliverables with scientific clarity and accuracy • Ability to manage study-related medical writing activities with minimal supervision • Knowledge of ICH E3 guidelines and applicable regulatory standards • Ability to follow company SOPs, client standards, approved templates, authorship requirements, and style guides • Experience coordinating quality and editorial reviews • Ability to review statistical analysis plans and table, figure, and listing specifications • Ability to collaborate with clients and cross-functional teams including data management, biostatistics, regulatory affairs, and medical affairs • Ability to perform clinical literature searches and comply with copyright requirements • Ability to provide technical support, training, and consultation • Ability to mentor and lead less experienced medical writers • Knowledge of industry topics and regulatory requirements affecting medical writing • Ability to work within budgeted hours and communicate project status • Minimal travel availability 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 • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time