Manager/Associate Director of Regulatory Medical ...

Join Syneos Health as a Manager/Associate Director of Regulatory Medical Writing Syneos Health is at the forefront of biopharmaceutical solutions, dedicated to accelerating client success. We bring unique insights from clinical, medical affairs, and commercial sectors to tackle contemporary market challenges. Our Clinical Development framework places the customer and patient at the core of our operations. We are continuously seeking innovative ways to streamline our processes, not only making Syneos Health easier to collaborate with but also a more fulfilling place to work. Be part of a passionate team dedicated to transforming lives and delivering therapies efficiently. Explore the impact of our 29,000 employees across 110 countries. Your Role and Responsibilities Manage project-specific tasks for medical writing staff, including overseeing salary administration, recruitment, performance appraisals, and professional development. Review and edit departmental outputs to ensure they meet quality standards for completeness and accuracy. Maintain adherence to Sponsor objectives while ensuring high-quality standards are met. Support the medical writing leadership team in strategizing document development and presenting quarterly business updates. Assist with preparing budgets and timelines for medical writing activities related to clinical development projects. Facilitate project metrics tracking and contribute to departmental performance metrics. Support business development efforts by assisting with proposal development and customer meetings. Develop productive relationships with internal and external customers and lead cross-functional teams. Review the performance of medical writing team members and provide guidance as necessary. Create and maintain departmental Standard Operating Procedures (SOPs) and templates. Participate in the planning and writing of medical writing deliverables when required. Conduct senior reviews of medical writing outputs, as well as reviews of statistical analysis plans and related documents. Undertake additional relevant duties as assigned, with potential travel required (up to 25%). At Syneos Health, we are committed to fostering an environment where our people can thrive and develop. We offer valuable benefits including health coverage, a 401k match, employee stock purchase eligibility, performance bonuses, and flexible paid time off. Salary Range: $95,000.00 - $175,700.00 Please note that actual salary will depend on qualifications, skills, and experience. Discover Syneos Health In the past five years, we have partnered with 94% of all novel FDA-approved drugs and 95% of EMA authorized products. We have contributed to over 200 studies globally. No matter your role, you are encouraged to drive initiative and innovation in a competitive landscape. Join us and shape the future at Syneos Health. Tasks and responsibilities may evolve as required or as deemed necessary by the company. The description does not constitute a contractual obligation.

Created: 2026-03-06