Manager, Standards and Governance (m/f/t/i)

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Standards & Governance Manager (m/f/t/i)

Summary: The Standards and Governance Manager is responsible for driving governance and implementation of local business processes at the Affiliate level. He/She is playing a key role in operationalizing the local business processes that support the implementation of the Corporate Compliance Program, working in close partnership with the designated Corporate Compliance Officer (CO) and local business departments. He/She focuses on business process conception, implementation and enhancement, strategic advice on continuous improvement of the supporting processes, SOP's and Work Instructions supporting the Corporate Compliance Program through ongoing consulting, feedback and monitoring, training on local processes as warranted, strategic and operational support to the Affiliate on matters related to Corporate Compliance SOP/Policy implementation, and coordination of the local approach to audit remediation and risk management design.

Accountability Description

• Operational maintenance of localized Compliance Program elements
• Drive localization of business processes (drafting supporting localized SOPs, Work Instructions, cadence management, support translations, archiving)
• Lead and support in managing localized operational process requirements, i.e. o approval processes; o needs assessment or application forms and respective processes; o fair market value calculation process; o implementation of external and global and local internal requirements o adequate and sufficient documentation
• Structure, review and define requirements for process tools (e.g. ZINC, ESE Tool, FoundationConnect)
• Advise and support on required process or form changes
• Provide day-to-day advice as to adherence to, and requirements of, local processes
• Consult in, assess and answer Compliance and Governance questions by employees, evaluate and judge specific more sophisticated questions or projects (incl. adequate research) in close collaboration with Compliance, Legal or external experts and develop written guidance where required
• Define, establish, coordinate and track metrics for adherence to local processes to update management on Affiliate adoption and understanding of local business process requirements
• Provide operational support and execute communication / training on the FMV calculation system as implemented in the Affiliate to ensure that payments to HCPs are calculated in accordance with such system
• Design, review, evaluate and optimize Affiliate processes on a regular basis
• Regularly review and evaluate current Affiliate core processes
• Reveal potential risks and problem areas and streamlining opportunities
• Design new processes required due to external or external requirements
• Identify, elaborate and implement process enhancement and facilitation
• Advise business areas / departments on process coordination, review, definition and improvement
• Collaborate with CO in implementing localized Compliance Program, including Policies & SOPs
• Foster understanding of roles and responsibilities of employees with regards to implementation of localized Compliance Policies, SOPs and supporting processes
• Ensure that final versions of localized Compliance Policies are properly signed, stored, archived and accessible to Affiliate employees
• Process owner for maintaining any archiving system designed and implemented for managing records of the local/functional Corporate Compliance Program
• Training
• Give local input in the design of the Affiliate Compliance training plan (type of trainings, frequency, define audience & relevant schedule)
• Create adequate training material and act as trainer on localized Compliance related SOPs and business processes in collaboration with CO; provide training in accordance with agreed upon training plan
• Ensure that trainings (incl. training material) on Compliance Policies and localized SOPs are translated (as required and appropriate)
• Function as Training Coordinator managing Affiliate training environment in ISOtrain, e.g. assigning and changing training requirements for employees, maintain and keep up-to-date German Training Matrix, run respective reports and yearly training reviews
• Maintain records of training completions; discuss non-completeness with management team and CO
• Compliance Program Risk Monitoring and Risk Assessment
• Assist the CO and Affiliate in organizing the process, preparation, coordination and collection of information/documents for the Compliance Monitoring and risk assessment
• Perform/support execution of Compliance Monitoring as designated or as identified as a mitigation control together with the CO and/or Owning Department
• Collaborate with CO drafting local monitoring reports and defining remediation measures
• Support the CO and Affiliate in tracking any priority action items coming out of the Monitoring and risk assessment
• Raising awareness about and institutionalize Governance and Compliance
• Pro-actively communicate about and act as role model in governance and adherence to local business process requirements
• Translate global communications into local language as required and appropriate
• Coordinate, steer and follow-up regular Governance Affiliate Meetings and be an active member of the extended local management team bringing up key governance topics and aligning on an ongoing basis with the CO
• Support of Internal and External Audits
• Help Internal and External Audit understand the Affiliate Compliance Program, respective established processes and implemented operational and risk mitigation controls
• Assist the CO and local Management to organize for and provide Internal and External Audit with requested information and documentation
• Advise and assist CO and owning departments in answering their questions from Internal and External Audit regarding specific activities or transactions
• Transparency
• Provide strategic and operational advice for the Affiliate in implementation of appropriate systems and controls to ensure compliance with applicable local, regional and global transparency requirements and support the global transparency program as requested and as follows: o Provide detailed understanding of local processes and systems related to Affiliate specific transactions o Support Affiliate functions with regard to the implementation of payment disclosure systems in relation to applicable global, regional and local requirements o Provide transactional level understanding of local operations o Local project coordinator/lead to help identify Affiliate resources with the specific transactional and operational knowledge o Tracking and managing Affiliate response to project requirements o Reporting to management, CO and global teams on local project status o Support local reporting, documentation and aggregation of information

*LI-EU1

• Min. 3 years experience in similar role (ideally pharma / biotech industries)
• Knowledge of Healthcare Compliance Program requirements or experience in other defined governance roles (Audit, GxP)
• Experience with policy and procedure drafting and ma

The Standards and Governance Manager(m/f/t/i) is responsible for driving governance and implementation of local business processes at the Affiliate level. You will be playing a key role in operationalizing the local business processes that support the implementation of the Corporate Compliance Program, working closely with the Corporate Compliance Officer & local departments.