Thermo Fisher Scientific
Thermo Fisher Scientific Bulgaria Bulgaria
2 months ago
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 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 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 through feasibility support, involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), protocol deviation decisions and other documents requiring medical input
• Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead
• Serves as chief medical liaison between sponsor and all PPD internal departments performing the required tasks during all study phases. Liaises with Investigator sites by delivering a protocol specific advise on subject eligibility, protocol clarifications and safety concerns. lab procedures presentation and demonstration during an investigator meeting.
• Medical point of contact for all internal and external stakeholders: Interacts 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
• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
• Closely collaborates with the cross functional study team members i for medical risks, issues, and results to be clear to all involved parties
• MD, MB/BS or equivalent degree and a board certified specialist in Psychiatry
• Strong medical knowledge with robust clinical experience in Psychiatry
Knowledge, Skills, Abilities
• Experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is considered beneficial
• Is fluent in spoken and written English
• Strong communication & presentation skills
• A team player
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.
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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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
Medical Director - Psychiatry Bulgaria jobs
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