- 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, guidances 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 advises Commercial with respect to planning and prioritization of proposed promotional and disease state materials.
- Provides expert guidance related to Regulatory strategy to commerical and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials).
- Provides expert Regulatory guidance to Medical and other appropriate stakeholders with respect to GI Pipeline asset development activities which may include such functions as Patient Advocacy, Market Research (MR), Congress and Symposia 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 MLR 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 actively participates 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 ensures 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 centralisation 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 and/or experience which would allow the individual to function effectively in this role.
- 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, ability to 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, interdisciplinary, multicultural, 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
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
USA - MA - CambridgeWorker Type