Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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. 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, contributing to site selection, and reviewing and approving 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.
Real-time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well as study subject safety, while ensuring medical issues are identified early.
Consult with internal groups regarding procedural and budgetary items and the necessity for change due to protocol amendments. Educate Investigator sites by delivering protocol-specific lab procedures presentations during investigator meetings.
Medical point of contact for all internal and external stakeholders: interact with investigators, answer questions of IRBs and Health Authorities, and prepare and present material to the study executive and independent safety committee if applicable.
Ensure study compliance for all medical aspects by understanding and applying relevant SOPs and GCP.
Collaborate closely with cross-functional study team members to ensure medical risks, issues, and results are 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 the pharmaceutical industry, clinical trials, and pharmaceutical medicine.
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.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement.
Apply today! http://jobs.thermofisher.com
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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