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. 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 study teams, including creating clinical trial protocols, reviewing and approving study documents such as CSRs, ICFs, CRFs, and protocol amendments.
* Monitor clinical studies in real-time to ensure medical validity and subject safety, identifying issues early and consulting with the Global Medical Indication Lead as needed.
* Support protocol review, liaise with internal groups, and serve as the chief liaison between sponsors and internal departments during all study phases. Educate investigator sites and handle day-to-day activities to resolve issues.
* Act as the medical point of contact for stakeholders, interacting with investigators, IRBs, Health Authorities, and study committees. Provide medical training at investigator meetings and CRA training for new indications.
* Ensure study compliance with SOPs and GCP guidelines, and collaborate with cross-functional team members to clarify medical risks and results.
Education :
* MD, MB / BS or equivalent degree with strong medical knowledge and clinical experience, particularly in Neurology practice.
Knowledge, Skills, Abilities :
* Extensive experience in the pharmaceutical industry, clinical trials, and pharmaceutical medicine.
* Fluency in spoken and written English.
* Understanding of NDA submission processes and regulatory guidelines for adverse event reporting.
* Excellent communication and presentation skills, and strong teamwork abilities.
Apply today
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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