(Associate) Medical Director
hace 3 semanas
Company: Thermo Fisher Scientific - Barcelona, SpainSalary: NegotiableEmployment Type: Full-TimePositions Available: 1Work Schedule: OtherEnvironmental 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 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, 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 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.Act as the 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; provide medical training of site staff at Investigator meetings; CRA training in new indications.Closely collaborate with the cross-functional study team members to ensure that medical risks, issues, and results are clear to all involved parties.Education:MD, MB/BS or equivalent degree with strong medical knowledge and clinical experience running Cardiology patients in hospital practice.Board certified in Cardiology.Knowledge, Skills, and Abilities:Experience within the 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 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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Associate Director, Regulatory Affairs
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España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
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(Associate) Medical Director
hace 4 días
España Thermo Fisher Scientific A tiempo completoThermo Fisher Scientific - Barcelona, SpainDetailsNegotiableFull-Time1 positionAt 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...
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