Medical Affairs Associate
|Job Title:||Medical Affairs Associate|
|Contact Name:||David Lawrence|
|Job Published:||August 04, 2020 09:05|
Medical Affairs Consultant
Supporting a planned launch of an NBE in dermatology, as well as differentiation of through its life cycle, need to develop a cross-functional evidence plan that aggregates all data needs (clinical, nonclinical and real world data) to support regulatory, payer and HCP interactions.
Develop product maintenance and optimisation plan for the lead dermatology indication that aggregates areas of research to further optimise the appropriate use in the approved indication and explore use in potential new indications and build these plans by integrating information from all functions (through interviews, workshops, and review of existing plans).
*Develop a Cross-functional Evidence Plan for the life cycle of the product:
*Develop evidence plan template based on industry standards to be reviewed and approved internally
*Interview all Cross-functions in the Core Team of the project as well as Country Medical Affairs Leads to understand and document data needs in the several phases of the product life cycle
*Review individual function plans (Clinical Development Plan, Epidemiology Plan, Market Access Plan, Publication Plan…) and integrate key information in one single evidence plan
*Develop materials and conduct cross-functional workshops (approx. 5 workshops) to identify gaps in evidence plan
*Finalise plan to be presented to senior management for approval.
*Develop a Product and Maintenance Optimisation Plan (PMO) post-marketing and differentiation plan
*Based on findings of Gap analysis, draft trial objectives, design and eligible population for potential phase 3b/IV trials for review and approval
*Finalise PMO plan to be presented and approved by to senior management.
5 + years' experience in Medical Affairs, Rare disease
Ideally, launch experience with immunology/dermatology experience
Exceptional English communication skills
Experienced in running workshops and identify gaps in evidence plans
Experience in creating Product and Maintenance Optimisation Plans within the clinical environment
Initially, a 3-month role starting in late August/Early September fully remote