Global Medical Lead

Job Details

Job Type
Gilbert Khor
11 months ago
  • Single Contributor, Matrix Organization
  • Global Coverage
  • Clincal Research Management

Our client is a global pharmaceutical MNC, innovator to many leading brands across pharmaceutical drugs, vaccines and OTC products.

  • Provide portfolio support for respiratory assets through Medical affairs activities and support which includes lead & deliver internal and external engagements plan in line to the business needs
  • Collaborate and work closely with the marketing and commercial team & input into Campaign and material generation and ensure timely copy approval
  • Lead the medical content development
  • Accountable for medical disease and portfolio training to support the current and future business model 
  • Lead licence maintenance activities for all products under the incumbent’s responsibility such as DSUR, PBRER, PADs etc.
  • Accountable for generating scientific rebuttal on competitor publication and challenges and provide strategic inputs
  • Lead innovative Evidence generation including real world evidence / databases analysis
  • Work closely with life cycle management team and provide medical expertise and support to the project in scope
  • Accountable for portfolio publications and presentation
  • Regular participation and contribution to the Co-creation meeting for inputs to the medical strategy and content
  • Quarterly management monitoring
  • Adherence and delivering according to operation process
  • Provide medical/ scientific input to promotional campaigns. Develops promotional materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc) and that materials are adequately and correctly referenced
  • Develop and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DDP) is maintained in Datavision
  • Support the GMD in providing medical governance oversight for the asset, including assisting in the management of product-related issues/ crises including medical input into manufacturing issues
  • Lead license maintenance activities by providing strategical and technical expertise to support marketed portfolio for PREPS/ global regulatory filings/commercial interactions/new formulations/ indications/SKU reduction/authoring of regulatory responses/medical affairs
  • Provide medical input, reviews and approves Clinical R&D activities including risk-benefit assessment, participation in PIRC (Product Investigation Report Committee) meetings, synchronizing labels, PBRER safety reports, clinical overviews and central clinical response to questions from national regulatory agencies

  • 10-12 years of experience
  • Medical Degree (Clinical respiratory experience would be an advantage)
  • Copy approval knowledge / experience in the pharmaceutical industry, ideally at final or near to signatory status
  • Strong familiarity with and confidence in implementing compliance frameworks
  • Clear communicator with sufficient business acumen and experience to enable communication and engagement with key stakeholders supported by influencing, challenging and negotiating skills.
  • Knowledge and experience in phase 3b and 4 trials
  • Ready to travel for 30% 

Reg No. R1443092
EBC Connect Pte Ltd
Licence no. 17C8975