Medical Affairs Manager(

Job Number:

 190002W2)

Description

 

Galderma is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives. Galderma aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases.

For our GALDERMA PRESCRIPTION, GLOBAL SIG Rx organization, we are currently looking for:

 

MEDICAL AFFAIRS MANAGER (M/F)

The Medical Affairs Manager will coordinate and execute all operational activities related to IIT/ISS studies, Galderma local Phase 4 review by Global Phase 4 Review Committee, projects related to external engagement funding (HCPs experts, international professional societies, patient associations…) and will ensure timely Global Medical Affairs budget execution and tracking, within Global Medical Affairs Department. The role reports to the Head of Global Medical Affairs.

Activities and Responsibilities:

1. In close relationship with Medical Franchise Leads, coordinates medical affairs activities related to IITs/ISSs operational activities as per organization in place.

• As a member of the IIT Review committee (IITRC), collects all study concepts from requestors and organizes reviews by the IITRC at a regular basis


• Sets up the agenda, organizes the meetings, releases the minutes to the IITRC and requestors


• Records all decisions and minutes in the adequate registry


• Oversees initiation, follow-up and termination of projects


• Supports IIT contract agreement preparation and finalization


• Follows-up and consolidates financial aspects


• Follows-up study with Sponsor/Investigators to ensure collection of information (safety, regulatory, pregnancies…) and study report


• Supports any related activity.

2. In close relationship with Medical Franchise Leads, coordinates medical affairs activities related to local and global Phase 4 studies, as per governance rules (Phase 4 review committee, GPRC) in place.

• As a member of the Phase 4 Review Committee (GPRC), collects all study concepts from country or from global team requestor and organizes review by the GPRC at a regular basis


• Sets up the agenda, organize the meeting, release the minutes to the GPRC and country requestor


• Records all decisions and minutes in the adequate registry


• Oversees initiation, follows-up and terminations of local projects


• Follows-up study with the requestors to ensure collection of information (safety, regulatory, pregnancies…) and study reports


• Supports any related activity

3. In close relationship with Head of Patients and Professionals Engagement, coordinates and executes operational activities related to external engagement and global funding requests (GFR) from external patients associations, healthcare professionals and international professional societies.

• Prepares and executes all GFR operational activities according to strict planning and respect of budget, regulatory, ethical and corporate communications aspects


• Ensures that all GFR activities and related external interactions are conducted and documented according to Galderma Medical Affairs Governance and International/Local compliance regulations


• Collects all GFR in liaison with Head of Patients and Professional Engagement and organizes reviews by the GFR Review committee (GFRRC)


• Records all decisions and minutes in the adequate registry


• Oversees initiation, follows-up and terminations of projects


• Manages GFR contract agreement preparation and finalization


• Follows-up and consolidate financial aspects


• Ensures adequate internal communication on GFR activities


• Contributes to the development and maintenance of the Customer


• Relationship Management system for profiling and mapping capabilities


• Manages the budget for GFR initiatives


• Coordinates Galderma sponsorships, grants and donations at international level


• Represents Galderma whilst interacting with external healthcare professionals and advocates.

4. Coordinates the Medical Affairs budget execution tracking

• Ensures the Purchase Orders (PO) and Purchase Requests (PR) are executed timely


• Monitors and controls activities in the planning/ tracking tool.
  

Education/Experience:

• Pharm D or University degree, preferably in a biologic/scientific discipline.


• Minimum of 5 years of proven experience in clinical operations or in Medical Affairs including 3 years of clinical project management or equivalent with Pharma/Biotech and/or CRO.


• Good understanding of products development and launch strategy, country level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.


• Ability to collaborate and engage cross functionally with diverse internal and external stakeholders.


• Experience in Medical Professional Relations initiatives and external interaction

Languages:

• English: Fluent spoken & written.


• Second EU language is the advantage: e.g. German or French.

 

  

Primary Location

: Switzerland-VD-La Tour-de-Peilz

Job

: Other

Organization

: Galderma

Schedule

: Full-time

Job Posting

: May 21, 2019, 4:08:15 PM