Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred
About The Position
Syneos Health is a leading fully-integrated life sciences services organization focused on accelerating customer success. The Clinical Solutions team members operate with a drug development mindset, leveraging their expertise to understand and shape solutions for customer needs. This role involves collaborating with passionate problem solvers in an agile and driven environment to achieve customer goals. The company emphasizes people development through career progression, training, and recognition, and is committed to building an inclusive culture. The purpose, 'Driven to Deliver,' reflects the colleagues' passion for shaping solutions that significantly impact lives. Syneos Health aims to shape the future of healthcare by bringing together diverse colleagues, driving impact for customers, and defining the pace of patient progress.
Requirements
- Develop regulatory documents for submission to regulatory agencies globally¾including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
- eCTD submission experience preferred.
Nice To Haves
- Oncology Preferred
Responsibilities
- Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards, and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
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
