Senior Medical Writer (FSP) - Clinical document writing experience (Protocols, CSRs and IBs)
About The Position
Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. In this role, you will collaborate with passionate problem solvers in a Functional Service Provider partnership or Full-Service environment, innovating as a team to help customers achieve their goals. The company is agile and driven to deliver for its colleagues, customers, and those in need. Syneos Health is committed to developing its people through career development, progression, supportive management, training, and a total rewards program. They are dedicated to building an inclusive culture where employees can be authentic, driven by a purpose to shape solutions that dramatically impact lives. They continuously strive to build a company that is desirable to work for and to work with, believing that bringing together diverse colleagues shapes the future of healthcare and defines the pace of patient progress.
Requirements
- Clinical document writing experience (Protocols, CSRs and IBs)
- Experience with ICH E3 guidelines
- Experience with company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides
Nice To Haves
- Experience with patient narratives
- Experience with annual reports
- Experience with investigator brochures
- Experience with informed consents
- Experience with plain language summaries
- Experience with periodic safety update reports
- Experience with clinical development plans
- Experience with IND submissions
- Experience with integrated summary reports
- Experience with NDA and eCTD submissions
- Experience with journal manuscripts
- Experience with abstracts, posters, and presentations for scientific meetings
Responsibilities
- Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
- Manages medical writing activities associated with individual studies, 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.
- Coordinates quality and editorial reviews.
- Ensures source documentation is managed appropriately.
- Leads team document reviews, and reviews documents as needed.
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
- 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 relations with clients, department head, and peers 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.
- Provides technical support, training, and consultation to department and other company staff.
- May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
- Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
- Completes required administrative tasks within the specified timeframes.
- Performs other work-related duties as assigned.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
