CSL Behring

KNG OF PRUSSA, PA

Senior Manager, NA Business Integrity

$97,000-$233,000 / YEAR
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

The Senior Manager, North America (NA) Business Integrity (BI) will be responsible for providing comprehensive compliance and business risk-management advice and support to NA Commercial Operations (Com Ops) functions within CSL Behring's NA bio-pharmaceutical business. The Senior Manager, in alignment with regional and global Business Integrity leaders, will be responsible for the development, implementation and effectiveness of compliance strategies and compliance program elements for assigned areas of responsibility.

Responsibilities:

1- Serve as primary US Commercial Operations SME and manage a variety of critical, time sensitive BI assignments, with focus on Marketing, Sales, Business Operations and Healthcare Systems.
  • In collaboration with NA and Global BI leadership and key Business Partners, set strategic BI priorities for US Commercial Operations in full alignment / coordination with US-based and Global Com Dev, as well as Regional / Global BI Leadership.
  • In collaboration with NA BI and USCO Leadership, direct and develop US Commercial Operations compliance program strategy, priorities, elements (e.g. SOPs), operations consistent with global program priorities and objectives.
  • Serve as day to day coordinator of delivery / manage implementation of BI support for USCO
  • Lead the active engagement, communication and training plan of Policies, Practices and Procedures, in alignment with US Commercial Operations Leadership, to establish BI as integral to the success of the entire NA Commercial Operations organization.
    • Coordinate and align subject matter experts from Legal, Medical Affairs, Finance, Communications and other relevant business functions in order to provide resources and expertise needed for an effective BI impact on US Commercial Operations.
  • Ensure BI has insight, and provides direction (as needed), for essential Brand and Operational area strategic plans and tactics, such as;
    • Engagement of HCPs for services such a Promotional Speaker programs, Advisory Board annual planning and delivery, consulting services etc.
    • Patient Engagement activities including Patient Advocate engagements, Promotional programs or Advisory Boards with Patients or Patient Advocacy groups.
    • Conference and Convention plans
    • US Sponsorships, Donations and Grants.
    • US Marketing external communication via websites or other social media
  • Proactively develop strategy, communication and alignment with Global BI counterparts to integrate and streamline processes and procedures for US Commercial Operations. Such as;
    • Global, cross-border engagement of HCPs for services
    • Transparency reporting requirements as required for US Federal, State and cross-border ex-US engagements
    • Privacy - data management / US State requirements or cross-border transfer
  • Create a comprehensive Compliance-focused onboarding process for new US Commercial Operations employees as well as a comprehensive training program delivered in either a scheduled or an ad-hoc manner depending on identified needs.
  • Develop and lead annual risk based monitoring process, including annual transaction reviews for prioritized US Com Ops risk areas, develop remediation plan and report in coordination with Regional BI Director


2- Assist Director NA BI in assuring oversight and effectiveness of BI compliance support for NA Commercial Operations (US and Canada)
  • In collaboration with NA Director and Global BI leadership and key Business Partners, support development and delivery of strategic BI priorities for NA Commercial Operations in full alignment / coordination with US-based and Global Com Dev, as well as Regional / Global BI Leadership.
  • Direct BI compliance support for designated NA Com Ops functions as needed.


3- Manage regular USCO SOP review, refresh and communication at direction of NA BI and US Commercial Teams

4- Serve as NA BI primary point of contact for Plateau team in order to facilitate timely and effective delivery, monitoring and reporting of compliance training

Qualifications:
- Bachelor's degree is a minimum requirement. Advanced relevant degree or certification is preferable (e.g. MBA, JD, CPA, other)

- Minimum 4 -7 years of experience with demonstrable expertise relevant to NA bio-pharma best compliance practices and risks, including experience supporting pharma/ other healthcare compliance program and/or in pharmaceutical marketing, sales, healthcare systems (Corporate Account / IDN), Medical Affairs or other business role with significant hands-on responsibility for compliance requirements or activities.

- Demonstrated working knowledge of core pharmaceutical / healthcare law, state and federal regulations (such as FCPA, AKS, and Open Payments) and national (PhRMA / ICM) codes of conduct. Additional experience in Audit, Legal or Finance functions may add useful depth and insight to support success in this role.

Worker Type:
Employee

Worker Sub Type:
Regular