Compliance - HCP Engagement Lead – Pharma at Shionogi Inc. in Florham Park, New Jersey

Job Description:

 The HCP Engagement Lead manages Compliance processes related to evaluation and execution of Healthcare Professional (HCP) engagements and interactions with Healthcare Organizations (HCOs).  Will support the needs of business owners while simultaneously ensuring potential risks are evaluated and mitigated appropriately.  Will also serve as a core member of the Compliance Team and represent Compliance on committees related to HCP/HCO activities.

RESPONSIBILITIES

• Manage the Compliance Review Committee (CRC) process, which has corporate responsibility for ensuring appropriate interactions with HCPs and HCOs;


• Conduct substantive review of all requests for engagement of HCPs and interactions with HCOs that are submitted to Shionogi’s CRC. Review includes, but is not limited to, an evaluation of the following parameters:  needs assessments, activity details, HCP attributes and credentialing, activity venue (if applicable), Shionogi participants, accounting for deliverables, etc.;


• Work closely with CRC Coordinator to ensure that requests are reviewed in a timely manner;


• Liaise with business owners to ensure understanding of business needs and project details;


• Conduct HCP licensure checks, debarment screenings, exclusion screenings, and other diligence,
  as required, relevant to HCP engagements;


• Review and apply output from Medical Affairs HCP credentialing process. Escalate exception requests to Vice President, Compliance, as required;


• Manage the process for determination of Shionogi’s FMV rates. Identify and assign appropriate Fair Market Value (FMV) rates for HCP engagements utilizing Shionogi’s FMV Rate Card;


• Populate HCP contracting templates as required by engagement type;


• Collaborate with Shionogi Legal on HCP/HCO requests for contract modifications;


• Serve as Compliance representative during Medical Review Committee (MRC) meetings, as needed (Compliance is an ad-hoc member of the MRC);


• Liaise with colleagues in Japan and Europe on multi-regional projects related to HCP engagement. Drive consistency and optimization of processes for cross-border HCP engagements; and


• Support the VP Compliance in additional activities, as requested, which may include but not limited to the following: periodic monitoring and auditing of HCP activities; internal investigations related to HCP/HCOs; inquiries related to HCP spend data reporting (e.g., Sunshine Act review/disputes).

 REQUIREMENTS 

• Bachelor’s Degree required; additional paralegal or legal training preferred.


• 5 plus years of Compliance and/or Legal Department work experience in a regulated industry such as: Pharmaceutical, Medical Device and /or other Life Science industry.


• Able to draft contractual documents and have familiarity with related laws.


• Self-motivated, proactive, and able to manage tight deadlines and/or multiple projects with limited supervision.


• Strong organizational, analytical and interpersonal skills.


• Strong verbal and written skills; must be clear and concise with individuals and groups – internally and externally.


• Demonstrated success as a subject matter expert with regard to related compliance issues.


• Familiarity with government databases is preferred.


• Must be detail-oriented and show comfort as both a team player and an individual contributor.


• Should be solutions-oriented in approach to decision making.


• Travel is estimated not to exceed 15%.


• Proficient in MS Word, MS Excel, MS PowerPoint, Adobe Acrobat and technology in general.


• Ability to operate a computer keyboard, and to view video display terminal images up to four (4) hours at a time.

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

EEO 

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

Compliance