Senior Manager, MHI Compliance

AbbVie

Illinois

On-site

USD 120,000 - 180,000

Full time

5 days ago
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Benefits offered by this job

Paid time off
Medical/dental/vision insurance
401(k)
Long-term incentive programs

Job summary

AbbVie is seeking a Senior Manager to lead compliance monitoring for external interactions and field medical activities. The role involves implementing procedures for compliant scientific communications, updating guidance on regulations, and monitoring CRM entries to ensure high-quality records.

You will develop training resources, support role-based training plans, and report KPIs to mitigate risks across Global Headquarter, Affiliates, and cross-functional teams in Medical Affairs + Health

Qualifications

  • Bachelor’s degree (or ex-US equivalent) with related health science background: BSN, BS, BS Pharm.
  • Advanced degree (PhD, RN, PharmD, RD) or extensive Pharma/Biotech compliance experience preferred.
  • 5-7 years in Pharmaceutical/Biotech/Medical Device with Field Medical experience a plus.
  • Significant experience in Medical Affairs/Medical Operations with cross-functional leadership.
  • Ability to influence without direct authority with strong interpersonal skills.

Responsibilities

  • Execution of the compliance plan through monitoring of external interactions and field engagement.
  • Implement procedures for accurate, high-quality compliant scientific communications globally.
  • Stay updated on regulations and internal policies affecting external interaction procedures.
  • Monitor documentation related to CRM entries and active reporting.
  • Review and report compliance KPIs and risks to mitigate business impact.
  • Develop and support training resources for MHI teams on external interaction standards.
  • Support role-based training plans and ensure timely completion by MHI staff.

Skills

Leadership in Medical Affairs
Influence without authority
Regulatory/compliance experience
Cross-functional collaboration
Training program design

Education

Bachelor’s degree in health science
Advanced degree preferred

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Reporting to the Director, MHI Compliance and Independent Education, External Interactions, the Senior Manager, is accountable for compliance monitoring supporting effective implementation of standards governing external interactions and field medical activities. In accordance with the principles for maintaining a high-quality compliance program, the Senior Manager will implement written procedures and monitoring to support compliant field medical activities. This role will contribute to effective training, conduct monitoring/auditing and recommend and implement corrective and preventive actions. Primary areas of responsibility will include field engagement and documentation standards. This role is responsible for building positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups across Global Headquarter, Affiliates, therapeutic area teams, Regulatory Affairs, Legal, Office of Ethics and Compliance (OEC) and all functional areas of Medical Affairs + Health Impact (MHI).

Responsibilities:

  • Execution of the compliance plan through monitoring of activities related to external interactions and field engagement.

  • Implement procedures to support accurate, high quality and compliant scientific communications for AbbVie globally.

  • Actively pursues updates to guidance on regulations and internal policies and their impact on external interaction procedures.

  • Implement procedures to support accurate, high quality and compliant documentation related to entries made into the company’s CRM through active monitoring.

  • Responsible for the review and reporting of compliance performance KPIs and related compliance monitoring for external interactions to mitigate business performance risks.

  • Develops and supports the delivery of supplemental training resources and communications to relevant MHI team members to enhance understanding of the minimum standards for external interactions with healthcare professionals (HCPs).

  • Supports completion of required training by MHI employees through development, maintenance, and reporting of role-based training plans.

Qualifications
  • Bachelor’s degree (or ex-US equivalent) with related health science background: BSN, BS, BS Pharm. Advanced degree (PhD, RN, PharmD, RD) or extensive experience in Pharma/Biotech Compliance, Operations and/or performance excellence is preferred.

  • 5-7 years of experience in Pharmaceutical, Biotech or Medical Device industry with Field Medical experience a plus

  • Significant experience (>3 years) in Medical Affairs, Medical Excellence, Medical Operations or a related pharmaceutical/biotechnology function, including leadership of cross-functional initiatives.

  • Experience developing and implementing monitoring oversight for business execution, including reporting and metrics preferred but not required.

  • Ability to influence others without direct authority.

  • Excellent leadership, self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed

  • Previous experience in situations of conflict resolution, problem solving, or crisis management preferred. Excellent interpersonal, communication (both oral and written), and relationship building skills.

  • Able to operate effectively within a matrixed environment, embrace change, and lead implementation of new initiatives; can decide and act without having the total picture and can comfortably handle risk and uncertainty.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

  • The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

  • This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

What AbbVie Has to Offer

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.

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