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Discover Impactful Work

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.

As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.

The Associate / Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities.

Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR)

A Day in the Life

General Support :

• Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs / directives and project specific WPDs for assigned projects. Adheres to PPD's corporate policies and SOPs / WPDs.
• Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as requested.
• Assists in writing (interpretation of safety and efficacy data) and / or review of CSR, IND / NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

Clinical Trial Support :

Marketed Products Support :

Keys to Success

Education and Experience :

For Medical Director Level :

In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Job leveling at Associate Medical Director or Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results.

Knowledge, Skills and Abilities :

Physical Requirements / Work Environment :

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!