Job Description The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise
* Responsible for preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures
Be part of a critical member in the RA organization. Lead in RA development/strategy activities to obtain product approval for various unmet medical needs. Client Details * Global leading pharmaceutical business specialising in womens health *
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market. Client Details * Global medical device company operating in 40 countries around the globe * Specializing in up to
Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements Client Details * One of the top global biopharmaceutical companies in
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market. Client Details * Global cosmetic medical device company * Specializing laser treatment for skin treatment * year on year
