Medical Information & Medical Compliance Manager

About Us

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan , Doliprane , Dulcolax, Enterogermina , Essentiale and Mucosolvan . As a globally certified B Corp company, we are active players in the journey towards healthier people and planet . Find out more about our mission at www.opella.com .

Position Overview

The objective and purpose of the Opella China (Associate) Medical Manager – Medical Information, Medical Compliance, with other responsibilities position is as follows:

• To set up and manage Opella China Medical Information operational system to satisfy business needs and be compliant with global and local, internal and external requirements.
• To arrange systematic training plan for Opella China Medical team and specific training plans for different Medical roles, including but not limited to general trainings for onboarding, compliance, medical capabilities, internal systems, guidances and SOPs, disease and product knowledge trainings, internal and external medical GxP relevant trainings, and training for general capabilities and skills; to ensure, arrange, and make trackable records of the execution of training plans.
• As Opella becoming stand-alone, to absorb Medical Excellent/BOS team’s responsibilities which are to be transferred to Opella local Medical team, esp. those relevant to supporting for the process workflow of the EET process.
• As CHLOE project (Opella becoming stand-alone) goes on, to set up medical compliance operational system/process for Opella China, and to provide medical compliance operational guidance for medical, marketing, and medico-marketing activities.

ACCOUNTABILITIES

The objective and purpose of the Opella China (Associate) Medical Manager – Medical Information, Medical Compliance, with other responsibilities position is as follows:

• To set up and manage Opella China Medical Information operational system to satisfy business needs and be compliant with global and local, internal and external requirements, including but not limited to:
  • Creation and maintenance of response documents
  • Training of Contact Center on Opella-specific products and topics
  • Quality Checks of Opella related inquiries
  • Management of and responses to escalations of medical inquiries
  • Management of Opella-specific local MI phone numbers.
  • MI input into launch teams, crisis teams, etc. and coordination of related activities.
  • Development and testing of Opella-specific system requirements.
  • Input into product dictionaries for Opella products in system.
  • Generation of metrics, reports, dashboards and insights.
  • MI input to BD activities (product divestments, acquisitions) .
  • Management of specific Quality Documents .
  • Management/contributions to relevant audits and inspections
  • MI representation at conferences, etc.
  • Any other local MI activities.
• To arrange systematic training plan for Oella China Medical team and specific training plans for different Medical roles, including but not limited to general trainings for onboarding, compliance, medical capabilities, internal systems, guidances and SOPs, disease and product knowledge trainings, internal and external medical GxP relevant trainings, and training for general capabilities and skills; to ensure, arrange, and make trackable records of the execution of training plans.
• As CHLOE project (Opella becoming stand-alone) goes on, to set up medical compliance operational system/process for Opella China, and to provide medical compliance operational guidance for medical, marketing, and medico-marketing activities.
• As CHLOE project (Opella becoming stand-alone) goes on, to absorb Medical Excellent/BOS team’s responsibilities which are to be transferred to Opella local Medical team, esp. those relevant to supporting for the process workflow of the EET process.
• To build strong cross-functional relationships with colleagues in Medical Affairs, Clinical Affairs, and Commercial Operations, while maintaining full compliance with all relevant company, industry, legal, and regulatory requirements. Ensure a clear review process for all Medical related programs and activities prior to final approval, which including but not limited to Medical Education Meetings, Advisory Boards Meetings, Steering Committees, Sponsorship, Partnership, Patient Support Programs, Market Research programs, Medical Liaison programs & activities, etc.