(Associate) Medical Director

hace 5 días

España Thermo Fisher Scientific A tiempo completo

Thermo Fisher Scientific - Barcelona, SpainPosition Type: NegotiableEmployment Type: Full-TimeNumber of Positions: 1Work Schedule: Standard (Mon-Fri)Environmental Conditions: OfficeAt 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Discover Impactful Work:The (Associate) Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the 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, and 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, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Acquire other functions’ dedication to close gaps and address issues timely and effectively. Serve as chief liaison between sponsor and all PPD, part of Thermo Fisher Scientific internal departments performing the required tasks during all study phases. Educate Investigator sites by delivering a protocol-specific lab procedures presentation and demonstration during an investigator meeting. Control, handle, and follow day-to-day activities during the course of the clinical trial to resolve any issues and answer queries.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 Neurology patients in hospital practice.Knowledge, Skills, Abilities:Significant experience within pharmaceutical industry, clinical trials, and pharmaceutical medicine is critically important.Fluent 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.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.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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