Senior Compliance Officer

US-NJ-Jersey City
ID
2018-1079
# of Openings
1
Category
Legal

Overview

The Senior Compliance Officer will support MTPC’s pharmaceutical businesses in the USA by providing providing compliance services and support primarily to MT-US. This is a dynamic role giving advice on compliance issues as they arise from the sales, market access, medical, operations, clinical, safety, regulatory, medical, sourcing, business development, research collaboration, and executive teams of MT-US.

The incumbent will be involved in the creation and implementation of all aspects of the compliance programs for each entity and operate as part of cross-functional teams focused on ensuring compliance with all applicable laws, regulations, rules, and policies and procedures. The Senior Compliance Officer will be responsible for evaluating strategic and tactical compliance program plans and advising clients on a broad array of issues relating to company policies and procedures, FDA pharmaceutical regulations, GxP requirements, anti-kickback, off-label promotion, competitor, regulatory, medical, industry and group company issues. The position will also be responsible for overseeing the compliance programs at each of the entities, including annual risk assessments, annual work plans, compliance committees, company-wide policies and procedures, compliance communications, company-wide training and education, investigations, enforcement, and corrective actions, acting as the Compliance Officer for each entity.

Responsibilities

  • Provides strategic advice regarding the compliance program for each entity, regulatory matters, compliance issues, and interactions with respect to pipeline pharmaceuticals. Ensures optimal advice regarding various compliance areas, including anti-kickback, off-label promotion, anti-trust, false claims, price reporting, and anti-competitive matters.
  • Drafts and reviews policies and procedures and training programs and advises management.
  • Partners with legal department colleagues at MCHA in New York City and Jersey City in executing and enhancing Company compliance objectives.
  • Drives increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the local businesses.
  • Emphasizes effective demand management, providing innovative solutions to meet client needs and address highest risks.
  • Works as part of a matrix leadership team at MTHA, MTPA, MTDA and MPH (handling compliance matters including clinical, regulatory, safety, medical, sourcing, finance, and HR).
  • Assists with support of legal and compliance function; helps to create and deliver policies and procedures and training to MTHA, MTPA, MTDA and MPH teams.
  • Leads by example and ensures consistent communication to MTHA, MTPA, MTDA and MPH.
  • Serves as a beacon of compliance as a representative of the MCHA compliance program.

Qualifications

  • Bachelors degree is required; Juris Doctorate (J.D.) degree is preferred

  • Minimum of 8 years of relevant experience at a major pharmaceutical company handling a broad range of complex compliance issues.
  • Experience with FDA regulations and guidance provided by the Office of the Inspector General for HHS is required.
  • Excellent oral and written communication skills; strong presentation skills, with the ability to communicate abstract ideas to executive and senior management.
  • Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to the company.
  • Strategic, analytical thinker and creative problem solver. who possesses innovation, client management skills, demand management skills and regulatory knowledge.
  • Selfless; promotes team and company objectives over individual accomplishments.
  • Strong organizational skills; ability to handle and prioritize a high volume of work and independently manage multiple complex projects simultaneously.
  • Demonstrated broad understanding of the business environment. Capable of anticipating future challenges resulting from change; proven ability to adapt quickly and keep up with fast‐paced, highly demanding environment and regulatory framework.
  • Ability to respond resourcefully and strategically to shifting priorities and work effectively in ambiguous or challenging situations.
  • Energetic self‐starter with demonstrated influencing skills and a results orientation. Must be able to quickly gain the trust and respect of senior executives, peers and clients.
  • Ability to work both in a strategic big picture mode, as well as tactically, including the capability to “roll up one’s sleeves” and work in detail.
  • Demonstrated client service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients while setting demand management and expectations for highest priority matters.
  • Willingness to travel to monthly staff meetings in New York City.
  • Ability to sit or stand for long periods of time
  • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
  • Ability to carry, handle and reach for objects
  • Ability to lift and pull up to 15 pounds

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