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Medical Writer Senior Principal
2 weeks ago
Syneos Health, Inc. is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model puts the customer and patient at the center of everything we do.
Job Description
We are seeking a highly experienced Senior Principal Medical Writer to lead the development of clinical documents for submissions to regulatory authorities globally. This role involves overseeing medical writing activities, mentoring junior writers, and developing regulatory documents in accordance with global guidelines and standards.
Responsibilities
- Develop clinical documents for submissions to regulatory authorities globally.
- Oversee medical writing activities for multiple compounds and serve as lead writer for individual summary documents.
- Mentor and lead less experienced medical writers on complex projects.
- Develop regulatory documents for submission to regulatory agencies globally, adhering to ICH and other global guidelines, standards, and processes.
- Lead and manage internal and external clinical medical writing activities associated with preparation, compilation, and submission of applications to regulatory authorities globally.
Qualifications
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree.
- Solid Principal Medical Writer experience gained from a CRO or Pharma.
- Excellent project management skills, including understanding of clinical timelines and working knowledge of roles of other functional areas.
- Strong verbal, written, and interpersonal communication skills to work effectively in a team environment.
- Proficient understanding and knowledge of global regulatory requirements.
