*description*
sr medical scientist
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. We are continuously looking for ways to simplify and streamline our work to not only make syneos health easier to work with, but to make us easier to work for.
Whether you join us in a functional service provider partnership or a full-service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. 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*
why syneos health
- 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.
*responsibilities*:
- works with medical director to develop medical plans (medical management plan, medical data review plan, and eligibility review plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.
- performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. Pro-actively identifies and resolves medical data review issues as they arise.
- authors medical data queries and reviews query responses, approves query closure in association with medical director.
- may assist medical director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of medical review summary report as needed.
- partners with medical directors for medical data review meetings and safety review meetings including slide preparation as needed.
- manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review.
- attends and present at trusted process meetings and may participate in internal and external audits.
- acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.
- adheres to all data privacy guidelines, international committee on harmonization (ich), and good clinical practices (gcps), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
- may manage limited number of direct reports. May participate or conduct interviews.
- works with medical director to develop medical plans (medical management plan, medical data review plan, and eligibility review plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.
- performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. Pro-actively identifies and resolves medical data review issues as they arise.
- authors medical data queries and reviews query responses, approves query closure in association with medical director.
- may assist medical director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of medical review summary report as needed.
- partners with medical directors for medical data review meetings and safety review meetings including slide preparation as needed.
- manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review.
- attends and present at trusted process meetings and may participate in internal and external audit