Thermo Fisher Scientific - Barcelona, Spain
Negotiable
Full-Time
1 position
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Discover Impactful Work:
The (Associate) Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.
A day in the Life:
Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials.During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquires other functions' dedication to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases.Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications.Closely collaborate with the cross-functional study team members in order for medical risks, issues, and results to be clear to all involved parties.Education MD, MB/BS or equivalent degree and strong medical knowledge, shown clinical experience running Cardiology patients in hospital practice.Board certified in Cardiology.Knowledge, Skills, Abilities Experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important.Fluency in spoken and written English.Understanding and experience with NDA submission process.Understanding of regulatory guidelines for adverse event reporting.Strong communication & presentation skills and is a strong teammate.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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