Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes
Job Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes.
The role involves leading the creation and review of a variety of clinical and regulatory documents while adhering to established regulatory standards and company procedures.
Syneos Health fosters a Total Self culture that values diversity, career development, and a supportive work environment where employees can be their authentic selves.
Matching Summary
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes.
Skills & Requirements
Must-have
Medical writing deliverables management
Disclosure platform experience
FDA and ICH regulatory knowledge
Clinical study document drafting
User acceptance testing experience
Strong English grammar skills
Nice-to-have
Collaborative and interpersonal skills
Project and time management skills
Mentoring less experienced writers
Technical support and training
Familiarity with AMA Manual of Style
Ability to interpret clinical data
Key Requirements
Minimum 4 years relevant disclosure platform experience
Bachelor's degree in relevant discipline
Strong understanding of FDA and ICH regulations
Experience with clinical study protocols and regulatory submissions