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- Supports the development of the strategic plans and studies to support patient access all within a highly matrixed, team environment + Communicates study findings to internal matrix and external (e.g HTAs/Payers, patient [advocacy groups] and KOLs etc.) audiences. + Develops and executes HEOR projects including writing RFP, vendor selection, and management including budget + Executes HEOR research using internal data sets including writing protocols and statistical analysis plans, defending in protocol review committee, and executing research with analyst to writing final reports or publications using prospective, retrospective, modeling, PRO's, meta analyses and hybrid designs. + Understands and translates into evidence solutions the strategic direction of the brand in partnership with the integrated brand teams focusing on the impact of evidence generation to solve complex issues + Partners with internal stakeholders where applicable such as development, on market cross functional teams, Medical Affairs, Market Access, and others, to execute on evidence needs of the asset. + Maintains awareness of regulatory legislation and assesses its impact on business and product development programs
- PhD in Health economics, pharmacoeconomics, health services research, public health or related field. Will consider MD or PharmD, both with an MS in Economics, Econometrics, or (pharmaco) epidemiology or any other related field. Prior experience in a pharmaceutical environment is preferred. Level commensurate with experience. + Possess both strategic and tactical skills in executing HEOR.
- Significant Work Activities and Conditions: N/A + Travel: Yes, 15 % of the Time
Regulatory Affairs Manager - Chicago, United States - SPECTRAFORCE
Description
Job Title :
Manager/Associate Director, Health Economics and Outcomes Research (HEOR)
Location: 100% Remote
Duration: 12 Months
Candidate Requirements:
s MS or PhD in Health economics, Pharmacoeconomics, health services research, public health or related field.
s Experience with development and execution of economic modeling strategies
s Experience with real-world evidence generation
s Experience with patient reported outcomes
Scope of Services for Potential Candidate for Epcoritamab
s Lead database analysis and real world data generation
s Develop recommendations for patient reported outcome measures
s Compile data plans, assess current evidence gaps/strategy
s Coordinate and contribute to HTA submissions
s Develop communication materials for cross-functional dissemination
s Draft and revise publications, manuscripts, abstracts and posters
s Collaborate and contribute to Economic and Patient Related Outcomes story
s Perform literature reviews and make literature based recommendations
s Address treatment landscapes
s Develop and/or review early economic models
Primary responsibilities include the following:
s Lead protocol development and real-world evidence in collaboration with the COE teams
s Develop early economic model for access/early pricing and reimbursement
s Develop communication materials, publications and congress submission materials
s Work with cross-functional teams and collaborations
Marketing
The Manager/Associate Director, Health Economics and Outcomes Research (HEOR) Hepatology/Virology will join a high caliber team to execute HEOR strategies and tactics for Hepatitis C and early pipeline assets in virology.
Director Hepatology/Virology to ensure project plans integrate and align with the product strategic plans from matrix teams to maintain leadership in Hepatology/Virology.
He/she helps to provide updates on execution of plans to products, development of product strategic plans, liaises with other members of the team to generate innovative ideas and create alignment on strategies.
Key Responsibilities Include:
Basic: