Syneos Health® is a premier biopharmaceutical solutions organization dedicated to accelerating customer success. With a commitment to bridging the gap between clinical insights and market realities, we place the customer and patient at the core of our operations. Our global team, comprised of 29,000 employees across 110 countries, is focused on simplifying the process of drug development, making it more efficient and effective for teams and clients. At Syneos Health, WORK HERE MATTERS EVERYWHERE.
Why Join Us?
We believe in developing our talent through career growth opportunities, engaging management, and a supportive workplace culture. Our Total Self culture allows employees to be authentic while fostering an inclusive environment. With a strong emphasis on diversity, we are continuously building a workplace where every employee feels valued and empowered to contribute
Job Responsibilities
As a Medical Writer II, you will play a vital role in crafting high-quality medical documents that adhere to regulatory standards and internal guidelines. Your responsibilities will include:
- Mentoring less experienced medical writers.
- Compiling, writing, and editing various medical writing deliverables, such as:
- Clinical study protocols and amendments
- Clinical study reports
- Patient narratives
- Annual reports
- Investigator brochures
- Reviewing statistical analysis plans for consistency, accuracy, and clarity.
- Collaborating with cross-functional teams, including data management, biostatistics, regulatory affairs, and medical affairs.
- Conducting peer reviews and addressing team comments to ensure clarity and consistency.
- Adhering to ICH-E3 guidelines and company SOPs for timely and budget-conscious document completion.
- Performing clinical literature searches as needed.
- Maintaining awareness of project budgets and timelines.
Minimal travel may be required (less than 25%).
Qualifications
We are looking for candidates who meet the following criteria:
- Minimum of 1 year of experience in medical writing, focusing on narratives.
- B.Pharm, M.Pharm, Pharm.D, Masters degree, Ph.D, MBBS, BDS, MDS
- Proficient in English grammar and familiar with FDA and ICH regulations as well as AMA style guidelines.
- Exceptional proofreading, presentation, and interpersonal skills with a strong team-oriented mindset.
- Proficient in Microsoft Word, Excel, PowerPoint, email, and Internet research.
- Strong ability to interpret and present clinical data effectively.
