Syneos Health · 3 months ago
Sr Principal Communication/ Publication Strategy - Single Sponsor - CMPP Certified
United States
Full-time
Remote
Senior Level, Lead/Staff
$95K/yr - $176K/yrSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Sr Principal Communication/Publication Strategy role involves leading complex medical writing deliverables, ensuring clear and accurate presentation of scientific information, and managing medical writing activities across studies while advising clients and study teams on data presentation strategies.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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 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. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately
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. Provides feedback to further define statistical output required and document needs
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. Works with staff across company to advance company priorities
Performs online clinical literature searches and complies with copyright requirements
Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities
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. Engages externally with industry groups on industry initiatives
Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Contributes to bid projections
Communicates status and changes to medical writing leadership; negotiates timelines and assigned deliverables
Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects
Completes required administrative tasks within the specified timeframes
Performs other work-related duties as assigned
Minimal travel may be required (less than 25%)
Qualification
Required
CMPP Certified
Experience in medical writing deliverables
Ability to manage medical writing activities with minimal supervision
Knowledge of regulatory standards including ICH E3 guidelines
Experience completing a variety of medical documents such as clinical study protocols, clinical study reports, and NDA submissions
Ability to advise clients on data presentation and production strategies
Experience leading document reviews and coordinating quality reviews
Expertise in reviewing statistical analysis plans and providing feedback
Strong interpersonal skills to build relationships with clients and team members
Experience performing online clinical literature searches
Ability to identify and propose solutions to resolve issues
Experience mentoring less experienced medical writers
Deep expertise in industry topics and regulatory requirements affecting medical writing
Ability to communicate status and changes to medical writing leadership
Experience representing the medical writing department on clinical study teams
Ability to complete required administrative tasks within specified timeframes
Willingness to travel minimally (less than 25%)
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
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Costa Panagos
Chief Executive Officer
Michael Bonello
Executive Vice President and Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase