Posted:2 months ago|
Platform:
Work from Office
Full Time
The main responsibilities are: Contribute to planning and Management of Clinical Development Program: Medical input to clinical development program(s) for phases 2 4 as applicable. Overall responsible for conduct part of the clinical trials - Clinical Trial Execution & Monitoring -Provide medical oversight during trial conduct of clinical development program, handle medical queries, protocol deviations, and ensure data accuracy through Clinical laboratory surveillance and Medical Monitoring. Responsible for medical oversight in delegated projects during execution and drive progress solving in trial-related issues, participate in Medical & Science Teams (MST), safety committees as applicable. Contribute with medical input to periodic updates of Investigators Brochure and review of medical content of Clinical Trial Reports as applicable Medical Device Support -Provide input on risk management, Supporting medical input to medical device technical file documentation and to other medical device development and life-cycle management activities Medical Coordination - Act as a liaison between core teams (e.g., Medical Specialists, line managers, GPTs) and ensure alignment with clinical development goals Compliance Support to Audit and Inspections - manage medical monitoring audits and support post-audit actions as a Subject Matter Expert (SME). The job is globally oriented, and Responsibility covers clinical product development worldwide. The job requires collaboration with stakeholders within Novo Nordisk global organisation and countries all over the globe. The job is geographically placed in BLR but has global scope. High degree of cross-cultural awareness is needed. We are looking for a candidate who meets the following qualifications: Medical Degree (MD/MBBS); advanced qualifications (PhD, or DM) is preferred and worked with Cardiovascular & Endocrine disorders. Proven experience in clinical development of new molecule or scientific roles such as clinician/physician, medical specialist, Principal Investigator/Co-Investigator for Phase 2-3 trials or related industry positions. Preferably skilled in medical expertise from Pharma/Biotech Company, experience in strategic planning and managing clinical trials and development in the pharmaceutical or medical device sector. Strong oral and written communication skills, including presentation abilities, in English as a business language.
Novo Nordisk
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