Purpose of the Job:
Support, facilitate and driving a compliance culture within the company across all business units through ensuring that company functions in a legal and ethical manner by maintaining high levels of business integrity and compliant ways of working:
- Responsible for developing, implementing and managing (incl. monitoring) compliance programs, reviewing company policies and advising on possible risks.
- Lead all key compliance projects including Business integrity, HCP transparency, data protection, anti-bribery and anti-corruption policies.
- Working as an effective business party with relevant functions
- Adherence to ABPI Code of Compliance and all relevant laws and regulations (incl. ABHI, PAGB).
- Oversee compliance aspects of relevant third-party providers
- Coordinating and scheduling required compliance training for employee through identifying and delivering well directed and necessary trainings
- Developing company compliance communications
- Process improvement and implementation
Key Responsibilities:
Business Integrity and Compliance processes and infrastructure:
- Manage the processes and SOPs that apply across the company and specifically for promotional affairs
- Leading local compliance programs with alignment to global directions
- Maintain a good working relationship with Global compliance team
- Identify compliance training needs across the organization
- Manage agreed audit areas address risks and gaps identified
- Proactively identifying gaps/issues and implement improvements
- GDPR involvement for UK & Ireland.
Meetings/TOV/MEGS:
- Manage the meetings approval processes
- Check meeting venues & accommodation are compliant with the Code
- Processing of all MEGS payments made to HCPs & HCOs
- Processing of HCPs sponsorships and ensure compliance with the Code
- Responsible for the collection of TOV data and the public disclosure of payments to HCPs and HCOs.
- Coordinating Funding Committee schedule to ensure the grant, donations and sponsorships applications are processed on time and on budget
Training:
- Training new starters and providing refresher training to ensure relevant staff are fully conversant with the appropriate Codes (e.g. ABPI, IPHA, PAGB, and MHRA Blue Guide).
- Veeva vault PromoMats approval training
- Managing the training roll-out of companywide SOPs
- Identify and address training needs
- Maintaining the training route for new final medical and commercial signatories
Promotional Affairs:
- Review promotional and educational material
- Become the expert in and manage the Veeva vault PromoMats electronic approvals process
- Supervise archiving and ensure that proper records of approvals are maintained
- Co-ordinate the re-approvals/ withdrawals process with the re-approval coordinators
- Take responsibility for the MHRA pre-vetting of relevant materials if required
Others:
- Manage the samples approval process
- Manage and respond to code related complaints (ABPI and inter-company)
- Developing and delivering the compliance communication to the organization
Profile Requirements and Competencies:
Key Skills / Experience Required:
- Education:
- Degree level education required
- Work Experience
- Proven proficiency with relevant Codes and Guidelines around UK Pharma promotion
- At least 3 years in the pharmaceutical industry within a legal or compliance role
PERSONAL ATTRIBUTES (see profile requirements above - plus)
Skills and Competencies :
- Proven influencing ability
- Demonstrable project management ability handling multiple projects
- Strong cross functional working skills and collaboration experience
- Excellent attention to detail
- Previous experience of using Zinc Maps, Veeva vault PromoMats or other copy approval systems
- Proven effective communication skill (written and verbal)
- Experience of writing and reviewing Controlled Documents, such as Policy, Standard Operating Procedures and Working Practices
- Experience in delivering training
Behavioural Competencies
The following areas are mandatory for high performance and progression:
- Collaboration and teamwork
- Performance driven
- Taking Accountability
- Externally focussed
