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 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)
Therapy knowledge in Respiratory
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.