Principal Medical Writer – Regulatory Submission
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Job Description
Medical writer developing global regulatory submissions for Syneos Health’s biopharmaceutical clients. Managing cross-functional timelines, quality documents, process improvements, and junior writer mentorship.
Responsibilities:
- Develop regulatory documents for global submission to regulatory agencies in accordance with ICH, global guidelines, standards, processes, and applicable Incyte authoring standards
- Manage medical writing projects, including timelines and communication with cross-functional teams regarding review cycles and expectations
- Participate in cross-functional meetings and provide input on medical writing deliverables, timelines, and processes
- Review associated project documents, including Protocols and Statistical Analysis Plans
- Participate in cross-functional process improvement initiatives
- Define and write standard operating procedures and best practices for efficient preparation of quality documents
- Manage internal and contract medical writing resources to ensure timely project completion
- Mentor junior medical writing staff
- Express interest for consideration in a potential upcoming opportunity and talent pipeline
Requirements:
- Experience developing regulatory documents for submission to regulatory agencies globally
- Knowledge of ICH and other global guidelines, standards, and processes
- Ability to adhere to study/project timelines and corporate objectives
- Ability to manage medical writing projects and develop timelines
- Experience communicating with cross-functional team members and participating in cross-functional meetings
- Ability to review project documents such as Protocols and Statistical Analysis Plans
- Experience with process improvement initiatives
- Ability to define and write standard operating procedures and best practices
- Ability to manage internal and contract medical writing resources
- Ability to mentor junior medical writing staff
- Equivalent experience, skills, and/or education may be considered
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture supporting authenticity and belonging
- Diversity, equity, and inclusion-focused workplace culture
- Remote work (Remote (Pre-Approved))
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