Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as our Head of Regulatory International Advertising and Promotion.
The Head of Regulatory International Advertising and Promotion is :
Accountable for the Global and Regional Medical, Legal and Regulatory (MLR) review process which defines the review of promotional and non-promotional materials and manages the development and implementation of the Company Review Standards outside the US.
Responsible and accountable for managing direct reports who support the approval of the Globally and Regionally produced promotional and non-promotional materials and activities
Responsible for managing direct report in the Operations Team who manage the Electronic Approval System (EAS) Veeva PromoMats.
As the owner of the Global and Regional Promotional and Non-Promotional Review Process supports the development and integration of the LOC review processes.
Oversee the development and implementation of directed and agreed future development and improvement of the review processes, standards and LOC specific requirements to ensure material is produced in a Compelling, Compliant and Timely manner.
Liaise with the US and Oncology BU Advertising and Promotion teams to ensure consistency across the business regarding Globally and Regionally produced material and activities.
Develop tools, reports, templates, business processes, training and communications to identify opportunities and creates mechanisms for improving the promotional and non-promotional review process.
Provide expert knowledge and comprehensive operational excellence from concept to delivery of promotional and non-promotional campaigns.
Implement the Digital Asset Management tools (Brand Portal) and future digital innovation to support CRM, omnichannel marketing and individualized promotional and non-promotional campaigns
How you will contribute :
- Provide expert regulatory review direction for Globally and Regionally developed promotional and non-promotional materials.
- In liaison with the leadership of Ethics and Compliance, Medical Communications, Medical Affairs, Commercial and Legal conducts detailed evaluation of the MLR process, Review Standards and adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with approved prescribing information.
- Lead the MLR leadership forum meetings for the Promotional and non-promotional approval process, to decide future review systems and processes and elevations of challenges in collaboration with Global, Regional and LOC representation.
- Drive the process of MLR reporting to analyze Global campaign effectiveness and process adherence.
- Make evaluations regarding regulatory acceptability of promotional programs and tactics. Frequently required to exercise and work in "grey" areas.
- Ensure expert feedback to regulatory strategy and labelling is provided during early development projects to ensure promotional goals can be upheld.
- Ensure IA&P analysis is provided within the development of the global regulatory strategy plan.
- Ensure that legal actions regarding promotional and non-promotional materials or activities (to or from competitors) are centralized and globally coordinated and identify potential competitor trends or risks that require further legal action.
- Ensure balance is upheld between regulatory compliance needs and commercial goals and develop solutions to achieve both. Provide evaluations and recommendations with advocacy being voiced for commercial issues.
- Resolve issues regarding regulatory acceptability of promotional programs and lead the integration of review processes and standards.
- Provide expert input during the development of Medical Devices and Digital Apps to ensure agreement on promotional code requirements.
- Provide guidance and review support to Corporate Communication to ensure compliant release of global press releases.
- Provide expert input during the development of clinical trials to ensure trial design and proposed end points are following regulatory promotional requirements for inclusion in future promotional campaigns and are acceptable as substantiation for promotional claims.
- Provide expert input during the development of patient retention material.
- Ensure regulatory input and review is provided for material and activities developed by Medical as part of the medical material review process.
- Foster a culture of interdepartmental discussion and agreement of review criteria to facilitate consistency and review quality.
- Manage direct reports to ensure the review processes and standards are upheld and Global, Regional and LOC requirements are assessed and addressed.
- Lead the IA&P LOC support model to address unmet LOC needs and to provide expert risk assessment of commercial materials.
- Inform GPLS and Regional leadership of important workload issues or areas of risk to ensure business continuity is guaranteed
- Encourage collaboration and communication globally across IA&P and between Global/Regional and LOC leadership
- Bachelor or Master's Degree in a science-related field
- 15+ years' experience in pharma industry including at least 5 years in Advertising and Promotion
- Understand EFPIA and International (ex-US) regulations basics on advertising and promotion for prescription products
- Multiple year's experience in International review and approval process of pharmaceutical/biologics promotion
- Understand of the basics in pharmaceutical promotion review process
- Demonstrate strategic and analytic thinking
- Clearly and concisely communicate.
- Negotiation, influencing without authority and working diplomatically through conflict.
- Proven people management skills.
- International travel may be required
- Attend offsite meetings that may involve overnight stay