Clinical Documentation Lead
hace 4 semanas
We are seeking a highly skilled Clinical Documentation Lead to join our team. As a Clinical Documentation Lead, you will be responsible for developing and implementing clinical documentation strategies, reviewing and revising clinical documents, and ensuring compliance with regulatory requirements.
About Us:
Syneos Health, Inc. is a leading integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our team is committed to building a diverse, inclusive, and authentic workplace where everyone feels like they belong. We believe in taking care of our people and providing them with opportunities for career development and progression.
Responsibilities:
- Develop and implement clinical documentation strategies
- Review and revise clinical documents, including clinical study protocols, clinical study reports, and patient narratives
- Ensure compliance with regulatory requirements, including FDA and ICH guidelines
- Collaborate with cross-functional teams to develop and implement clinical documentation processes
- Provide training and support to less experienced medical writers on clinical documentation procedures
Requirements:
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications, preferred) with relevant scientific and/or medical knowledge and expertise
- Extensive knowledge of English grammar with a familiarity with AMA style guide
- Understanding of FDA and ICH regulations and guidelines strongly preferred
- Demonstrated effective presentation, proofreading, and interpersonal skills and ensure a team-oriented approach
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information
What We Offer:
- Estimated salary range: $80,000 - $100,000 per year
- Competitive benefits package, including health insurance, retirement plan, and paid time off
- Opportunities for career development and progression
- Collaborative and dynamic work environment
About Syneos Health:
Syneos Health, Inc. is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
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