Locations: RochesterPark, Singapore
Categories:Medical and Clinical
Job description Site Name:
Singapore - Rochester ParkPosted Date:
Sep 11 2019
We have the opportunity to unlock the potential of our medicines across their lifecycle successfully on global basis - with patient safety being at the heart of everything we do. Our focus will be on supporting the Regions to fully realize the potential of all our medicines through portfolio solution of the CEP respiratory . This role will require close collaboration and travel ( 30-40%) to co-creation markets to deliver the current and future business needs for the Classic & Established Products (CEP) Respiratory portfolio.
To provide portfolio support for CEP 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 of CEP
- 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 CEP operation process
- Provides 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.
- Develops 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
- Supports 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.
- Leads 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.
- Provides 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 or Post Graduation Science degree (Clinical respiratory experience would be an advantage)
- Experience in above country medical role
- 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.
- Knowledge and experience in phase 3b and 4 trials
- Ready to travel for 30% to deliver EE and cocreation markets
Application closing date 4 Oct 2019
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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