Senior Principal Communication, Publication Strategy – CMPP Certified

🕒 January 27

🌵 Arizona, Maine, +3 more states – Remote

🌵 Arizona – Remote 🦞 Maine – Remote 🏖️ New Jersey – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

💵 $114k - $210.9k / year

⏰ Full Time

🟠 Senior

🗣️ Communications

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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

• Leads the clear and accurate completion of complex medical writing deliverables. • Completes a variety of documents including clinical study protocols and reports. • Advises clients and study teams on data presentation and production strategies. • Serves as expert peer reviewer for internal team, providing review comments. • Assures adherence to established regulatory standards in all written documents. • Interacts and builds working relationships with clients and team members. • Identifies and proposes solutions to resolve issues, escalating as appropriate. • Mentors and leads less experienced medical writers.

🎯 Requirements

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. • Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained. • Leads team document reviews and reviews documents for technical issues. • Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. • Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. • Performs online clinical literature searches and complies with copyright requirements. • Identifies and proposes solutions to resolve issues, escalating as appropriate. • Mentors and leads less experienced medical writers on complex documents. • Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. • Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables.

🏖️ Benefits

• company car or car allowance • Health benefits to include Medical, Dental and Vision • 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) and sick time