Vice President Medical Affairs

 

JOB DESCRIPTION:

 
Clinical Trials

  • Oversees the Clinical Development of MLC1501 under US FDA framework (phase I to commence in Q1 2018)
  • Evaluates proposal and need(s) for locally conducted clinical trials (mainly Phase III-IV), Post-Marketing Surveillance (PMS) studies, Observational studies, registry, and Externally Sponsored Studies (ESS);
  • Maintain and grows a network of academic cooperation as a platform for Moleac to implement initiatives
  • Writes the study concept, prepares the study synopsis & full study protocol;
  • Supervises the operational conduct of the trial (monitoring, compliance including GCP/ICH, reporting of adverse events…);
  • Performs the medical review of the data;
  • Assists the investigator in the preparation of study publications;
  • Manage relationship with publishing houses

International Operations

  • Guide the marketing team in the preparation of the different collaterals and communication supports
  • Mines field intelligence & data/publications to substantiate, update and improve the content of promotional messages and materials;
  • Assesses the accuracy of labelling & promotional messages concerning products & competition; reviews and approves promotional materials including external communication materials such as scripts for marketing teams, press releases, presentation during congresses, letters & positioning statements;
  • Guide the regulatory team in the proper gathering, evaluation, medical assessments and follow-up of adverse drug reaction events reported and of possible product complaints;
  • Oversees the creation, maintenance, and updating of standard product response messages; Implements and manages databases Training that tracks medical information requests and responses;
  • Contributes to publication of clinical data.

Assesses, develops, updates and implements briefings and training programs for the sales & marketing forces on processes, products and competition to enhance the overall understanding of the products, market environment as well as the regulations and guidelines that affect the products and services of the company; Customizes training programs according to the different needs;

Management

  • Team of 3- Medical Advisor for Product support (with marketing), Medical advisor for clinical trial , Medical Operations for Clinical trials implementation
  • Department budget

 

Other information:

  • Position based in Singapore
  • Job Type: Full Time

 

Application process:

Please send the followings to recruitment@moleac.com

  • Cover letter
  • Resume
  • Expected salary
  • Availability

 
We regret that only shortlisted candidates will be notified.