Senior Medical Writer
hace 4 semanas
We are seeking a highly skilled Senior Medical Writer to join our Clinical Development team at Syneos Health. As a key member of our team, you will be responsible for developing and implementing medical writing strategies to support our clients' clinical development programs.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects, ensuring high-quality deliverables and timely completion.
- Act as lead for assigned writing projects, overseeing the development of clinical study protocols, reports, and other regulatory documents.
- Manage medical writing activities associated with individual studies, coordinating with cross-functional teams to ensure seamless execution.
- Develop and maintain a deep understanding of regulatory requirements, including ICH-E3 guidelines, to ensure compliance and quality in all medical writing deliverables.
- Collaborate with department heads and staff members to produce high-quality writing deliverables, including clinical study reports, patient narratives, and clinical development plans.
- Review and provide feedback on draft and final documents, ensuring accuracy, clarity, and consistency.
- Stay up-to-date with current industry practices and regulatory requirements, applying this knowledge to improve medical writing processes and deliverables.
- 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, FDA and ICH regulations, and guidelines, as well as a familiarity with AMA style guide.
- Demonstrated high degree of independence, effective presentation, proofreading, interpersonal, and leadership skills, with 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.
Syneos Health is a leading fully 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. Our Clinical Development model brings the customer and the patient to the center of everything that we do, continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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