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Global, Value and Access Consultant
Ref No.: 18-29582
Location: Woodcliff Lake, New Jersey
Job Summary
The consultant is an intermediate-level, experienced professional who has worked at least 5 years in in the global HEOR department at a pharmaceutical company or companies as a contractor or full-time employee. This individual must be able to independently review drug product information (protocols, CSRs, landscape information) and develop an HEOR evidence generation plan and market access plan. This individual must also have experience in independently managing a variety of key HEOR project types such as SLRs, ITCs, GVDs, CEAs, BIMs, payer landscape assessments. This individual must also demonstrate strength in being able to conduct and critically evaluate at least 2-3 of these HEOR project types mentioned above. This individual must demonstrate an ability to effectively communicate technical information and market access strategy to members of the commercial, clinical development, medical affairs, biostatistics, and regulatory teams. This individual must be able to independently incorporate HEOR endpoints into RCT protocols, SAPs, CRFs, and write-up the HEOR data in the CSR.

This GV&A Consultant serves as a GV&A product lead on the relevant cross-functional teams, ensuring the following for each product:
• Management of collaborations with other departments
• Plan evidence generation needs and strategic imperatives
• Co-development of market access plans with the Global Market Access team (GMAT)
• Deliver timely, strategic, high-quality deliverables
The Senior Manager will fulfill the following objectives:
• Evidence generation plan development
• Perform targeted literature reviews to support strategy development
• Evidence gap assessment
• Clinical trial protocol & SAP review
• HEOR endpoint selection for clinical studies
• PRO development advice and execution
• Management of project vendors
• Delivering training and tool roll out
• Contract & budget tracking

The consultant will work within the Neurology GV&A therapeutic team reporting to the Executive Director, head of GV&A. The Senior Manager will be the product lead for their area and manage the timely completion of high-quality projects, and ensure alignment with product clinical and commercial plans under the oversight of the Executive Director, head of GV&A.

The consultant will be expected to be the product expert and be deeply familiar with all payer evidence requirements. This person will be expected to support local country pricing and reimbursement submissions and negotiations. As a corollary, the candidate should have a good working knowledge of the range of healthcare reimbursement systems and reimbursement guidelines.

This position is ideal for a candidate with a strong evidence generation and strategy development background.

Candidates should have excellent interpersonal and communication skills and work well in multidisciplinary, dynamic team environments.

Essential Functions
Responsibilities Percent of Time
Evidence generation and strategy development: 70
• Evidence gap assessment
• Evidence generation plan
• Project quality and strategic management
• Market access plans
• Targeted literature searches to develop strategy
• Clinical trial protocol & SAP review
• HEOR endpoint selection
• Local country submission support
• Tool roll out and adaptations
• Publications

Strategic business functions: 30
• Meeting attendance
• Management of collaborations with other departments
• Management of collaborations with partner companies
• Reporting and tracking of projects
• Compliance reporting
• Contract & budget tracking

Scope Measures
Thoroughness and appropriateness of evidence generation and market access plans quality and timeliness of project execution, quality of interactions with team members.

Knowledge/Skills/Abilities Required
• A postgraduate degree such as a PhD, MPH, or MS in a Health Services Research or similar field is required.
• 5 years of experience in an HEOR industry department is required.
• Competence in carrying out a variety of HEOR studies using a range of standard techniques
• Ability to work cross-functionally within teams
• Strong Excel model skills
• Effective analytical/problem solving skills, including generation of original and innovative ideas and solutions
• Action-oriented, customer-focused, with effective prioritization, goal-setting and time management skills
• Experience in the design claims analysis and observational studies is desirable
• Effective interpersonal skills; projection of professional image and credibility; teamwork oriented and inclusive
• Knowledge of the PRO guidance is necessary and experience is a plus
• Knowledge of health policy initiatives in any country is desirable
• Experience with supporting a payer submission in any country is desirable
• Knowledge of ISPOR guidelines is a desirable
• Peer-reviewed publications of original work in HEOR is desirable