- The Lead International Advertising and Promotion (A&P) serves as an internal expert on International, EFPIA regulations, guidance governing the promotion of prescription drug and biologic products and disease awareness activities.
- Capable of providing regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional and non-promotional materials generated for assigned products and/or compounds.
- Assists in the development, integration, and implementation of internal policies, work instructions, guidance s and regional and LOC specific requirements, in collaboration with the A&P Group Lead.
- The role serves as the process expert and is the lead for applicable A&P projects to ensure collaboration with key stakeholders and completion as planned.
- Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Ethics & Compliance organizations and applies expertise to ensure that the development of promotional and disease state materials is accomplished through compliance with internal processes and standards.
- Responsible for selected LOC s in a designated region to support the strategy and integration and implementation of the Local review process variations, working instructions and assist in local complaint management in order to ensure consistency with the International processes.
- Supports the development, integration and implementation of directed and agreed future development and improvement of the global review process, standards
- Evaluates materials to ensure compliance with International regulations, guidance, corporate standards and policies and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling. Provides consistent, well-supported, and clear guidance to key stakeholders.
- Serves as the chair of CMLR review meetings and assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
- Provides expert guidance related to Regulatory strategy to commercial and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials).
- Participates in CMLR meetings to resolve potential issues and participates in escalation meetings, as needed.
- Supports metrics to measure and track effectiveness and efficiency of the CMLR review process; provides recommendations for process improvements to address issues, gains agreement of process improvements from key stakeholders, and helps implement agreed-upon process improvements.
- Understands broad concepts within regulatory affairs and potential implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
- Leads internal A&P project workstreams (e.g., guidance documents) and active participant at team staff meetings
- Being the contact point and expert matter for the promotional review process and International review standards for selected LOC s within the designated region
- Supports the development, integration and update of the LOC processes and standards for promotional & non-promotional review and ensure full training implementation for selected LOC s within the designated region.
- Address unmet LOC needs for selected LOC s within the designated region through LOC discussions and the development of online collaboration tools.
- Being key contact person for selected LOC s within the designated region for complaints regarding promotional or disease awareness materials/activities in the designated region to drive centralization and global coordination and identify potential competitor trends or risks that require further legal action.
- Collaborates with the US CMLR review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns).
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in a science-related field
- Ability to understand EFPIA and International (ex-US) regulations basics on advertising
and promotion for prescription products
- Ability to understand the basics in pharmaceutical promotion development and review
- Strong interpersonal skills with ability to demonstrate strategic and analytic thinking
- Demonstrated ability to clearly and concisely communicate.
- Effective written and verbal communication skills in order to manage, motivate and drive decisions within teams.
- Proven skills in negotiation, influencing without authority and working diplomatically through conflict.
- Ability to work independently, take initiative and complete tasks to deadlines
- Previous experience in advertising and promotion; experience in managing regulatory filing(s) or competitor complaints or medical communication/information.
- Minimum of 3 year experience in International review and approval process of pharmaceutical/biologics promotion
- Leadership Skills - ability to effectively manage and bring working teams together for common objectives
- Strategic Approach - understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
- Analytical and Problem-Solving Skills - ability to understand complex issues and propose achievable solutions.
- Communication Skills - ability to express one s self clearly and concisely
- Interpersonal Flexibility- ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
- Teamwork - the ability to work well in a highly cross-functional team environment
- Presentation skills create and deliver presentations with appropriate messaging and focused recommendations.
- International travel may be required
- Ability to attend offsite meetings that may involve overnight stay
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.