Sr Principal Communication​/Publication Strategy - Single Sponsor

Sr Principal / Principal Medical Writer (Publication Strategy/Planning) - East Coast Preferred - Single Sponsor

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; 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 ICH E3 guidelines, as well as company SOPs, client standards, and approved templates, authorship requirements, and style/formatting guides, when completing medical writing projects, on time and on budget.
• Advises clients and study teams on data presentation and production strategies to meet client objectives/expectations and maintain quality standards.
• Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Serves as expert peer reviewer for the internal team, providing review comments to maximize clarity, accuracy, and relevance.
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Provides feedback to define statistical output requirements and document needs.
• Interacts with clients and internal stakeholders to produce writing deliverables. Works with staff across the company to advance priorities.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a technical SME and contributes to internal materials and presentations. Contributes to changes to internal processes and capabilities.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on key topics in the industry and regulatory requirements affecting medical writing. Engages externally with industry groups on industry initiatives.
• Aware of budget specifications for assigned projects, communicates status and changes to medical writing leadership. Contributes to bid projections.
• Communicates status to medical writing leadership; negotiates timelines and deliverables.
• Represents the medical writing department on clinical study teams, at conferences, meetings, and for client presentations regarding writing projects.
• Completes required administrative tasks within the specified time frames.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Salary Range: $95,000.00 - $

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, and proficiency for the role. Benefits may include company car or car allowance, health benefits, 401k with company match, eligibility for Employee Stock Purchase Plan, commissions/bonus eligibility, and flexible PTO/sick time. Paid sick time eligibility may vary by location in accordance with applicable laws.

Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Get to know Syneos Health:
Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

Additional information:
Duties and responsibilities may be assigned or revised at any time. The company may consider equivalent experience, skills, and/or education. This description does not constitute a contract. The company complies with applicable disability laws and provides…