Senior medical writer developing protocols and regulatory submission documents for Syneos Health, a life sciences services organization. Collaborating with clinical, statistical, regulatory, and medical affairs teams.
About the role
- Medical writer developing clinical protocols and regulatory documents for Syneos Health’s biopharmaceutical solutions. Coordinating reviews, regulatory compliance, and cross-functional study deliverables.
Responsibilities
- Partner closely with Clinical Scientists on protocols and protocol amendments
- Lead clear and accurate medical writing deliverables
- Manage medical writing activities for individual studies with minimal supervision
- Coordinate medical writing activities within and across departments
- Lead resolution of client comments
- Complete clinical study protocols, protocol 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, abstracts, posters, and presentations
- Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides
- Coordinate quality and editorial reviews and manage source documentation
- Lead team document reviews and act as an internal peer reviewer
- Review statistical analysis plans and table/figure/listing specifications
- Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions, escalating issues as appropriate
- Provide technical support, training, and consultation
- Mentor and lead less experienced medical writers on complex projects
- Develop expertise in industry topics and regulatory requirements
- Monitor assigned project budgets and communicate status and changes
- Complete required administrative tasks and other assigned duties
Requirements
- 3-5 years of relevant experience in medical writing, with proven experience in Protocol writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Experience with late development
- Experience with Oncology/Hematology/Cell therapy
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Experience in working with Veeva/CARA
- Extensive knowledge of English grammar and ability to communicate clearly
- Strong familiarity with AMA Manual of Style
- Equivalent experience, skills, and/or education will also be considered
- Minimal travel may be required (less than 25%)
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture
- Diversity, inclusion, and belonging-focused workplace
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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