Syneos Health

Senior Principal Communication, Publication Strategy – CMPP Certified

CommunicationsCommunicationsFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany Site LinkedIn

Location

Arizona + 4 more

Posted

50 days ago

Salary

$114K - $210.9K / year

Seniority

Senior

Bachelor DegreeEnglish

Job 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.

Job 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