Director, Promotional Review, Regulatory Affairs

Company: CNS-EXECUTIVE SEARCH
Location: New York
Posted on: September 25, 2022

Job Description:

The Executive Director, Established Brands Marketing is responsible for the overall strategic direction, and for leading the marketing and tactical execution, resource optimization, budget and sales achievement for the Established Brands, including Lifecycle Management. She/he is also responsible for leading two Centers of Excellence: Consumer Marketing and Opinion Leader Development & Advocacy. The Executive Director will also ensure all Established Brands marketing initiatives operate within full compliance of company regulatory and legal policies.BS with a Master's in Marketing, Business or Biological Sciences, preferred.
A minimum of 15 years CNS/neurology HCP and Consumer Marketing experience; in epilepsy, pain, and/or stroke prevention.
Prior product launch experience
Outstanding leadership and communication skills
Medical Director, Clinical Development & Medical Affairs, Neurology The Medical Director CDMA is responsible for providing oversight in the development and life cycle management for assigned products. This individual requires leadership skills necessary for the strategy, development, management, and implementation of Phase II-IV studies for assigned products, both within approved indication(s) and as pilot studies for new indications. The Medical Director is extensively involved with development colleagues, regulatory affairs, and the commercial organization. In addition, this individual is responsible for ensuring seamless transition of products from early development to late stage research.MD; if neurologist, board certified, preferred
A minimum of 5 years experience managing clinical trials for neurological disorders
Excellent understanding of various preclinical, clinical, regulatory, and commercial disciplines
Strong knowledge of GCP, scientific, and clinical methodology, protocol design, project management and regulatory requirements
Ability to build productive teams and develop high potential subordinates into leadership roles
Ability to facilitate and merge strong science into commercially viable products
Director, Contracts & Pricing The Director, Contracts & Pricing is responsible for the development, implementation and management of formulary access contracts with external customers including, but not limited to: MCOs, PBMs, and government program pricing (VA/TriCare/DoD and State Medicaid). This individual works cross-functionally with the Market Access account teams, Commercial Operations, Legal, Technical Operations, and Finance, in negotiations with customers through the preparation of bids, contract ROI analysis, contract terms/conditions review and contract performance/adherence reporting. In addition, the Director is responsible for managing all price calculation and rebate policies and procedures, and in reporting to government agencies on these procedures. He/she is also responsible for the analysis and business strategy support for formulary contracting strategy through the development of revenue management models that track utilization of company products through all business segments including commercial, GPOs, LTC, State Medicaid and Federal agencies (DoD/TriCare/VA)BS with a Master's in Finance or Business, preferred
Minimum of 8 years experience with a minimum of 2 years supervisory experience
Experience contracting with National, Regional, State Medicaid and Federal accounts with emphasis on price calculation methodologies and procedures for reporting
Strong in-depth knowledge of Market Access/Contract and Pricing practices (i.e., charge backs, rebates and Government pricing)
Excellent communication, presentation, and interpersonal skills
Experience launching products, or products in promotion, preferred
Director, Promotional Review, Regulatory Affairs The Director, Promotional Review, Regulatory Affairs is responsible for decision-making, direction and oversight of commercial regulatory issues in order to meet internal and external customer needs. All assigned Promotional Review projects will be managed and overseen by the Director, Promotional Review. Responsibilities include assurance of compliance with internal SOPs and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies.A bachelor's degree with a minimum of 8 years experience in Regulatory Affairs
In-depth experience of regulations and of advertising, promoting, and supporting commercial products
Excellent leadership and interpersonal skills with the ability to resolve conflicts
Must be able to provide creative solutions to complex problems
A Regulatory Affairs Professional certification (RAC), desired
The Product Manager is responsible for the development and execution of assigned Health Care Professional (HCP) and consumer promotion tactics supporting assigned brands. The Product Manager works interdependently to assure the Health Care professional and consumer healthcare tactics will achieve the desired business results. This individual ensures all the Healthcare and consumer healthcare strategies and tactics operate within full compliance of company's regulatory and legal policies.Bachelor's degree with a Master's in Marketing, Business, or Biological Sciences, preferred
Minimum of 4 years experience in CNS/neurology Health Care Professional and/or consumer marketing
Prior experience in MS, preferred.
Understanding of market research (including segmentation), forecasting, and market analytics
Excellent verbal, presentation, and written skills
Ability to effectively manage vendor relationships
CNS-ExecutiveSearch
Joan Bates -- Principal

Keywords: CNS-EXECUTIVE SEARCH, New York , Director, Promotional Review, Regulatory Affairs, Executive , New York, New York