Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Lead International Advertising and Promotion, Global Regulatory Affairs in our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Lead International Advertising and Promotion working on the Global Regulatory Affairs team, you will lead International Advertising and Promotion (IA&P) and serve as an internal expert on International, EFPIA regulations, guidance governing the promotion of prescription drug and biologic products and disease awareness activities. A typical day will include:
Provide regulatory strategic oversight for at least one (1) 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 IA&P Group Lead.
The role serves as the process expert and is the lead for applicable IA&P projects to ensure collaboration with key stakeholders and completion as planned in a timely manner.
Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Ethics & Compliance functions and applies expertise to ensure that the development of promotional and disease state materials is accomplished through compliance with internal processes and review 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 PRT 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 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).
Participates in PRT meetings to resolve potential issues and participates in escalation meetings, as needed.
Supports metrics to measure and track effectiveness and efficiency of the PRT 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 IA&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 centralisation and global coordination and identify potential competitor trends or risks that require further legal action.
Collaborates with the US BU & OBU review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns).
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BSc preferred; BA accepted, PharmD or PhD degree preferred
8+ years industry; inclusive of > 6 years regulatory or related experience. Less experience may be acceptable with PharmD or PhD degree.
1+ year work experience is desired in International review and approval process of pharmaceutical/biologics promotion.
Ability to understand European Federation of Pharmaceutical Industries and Associations (EFPIA) and International (ex-US) regulations basics as they apply to advertising and promotion of prescription products globally.
Desire to pursue a career in Global (ex-US) advertising and promotion.
Ability to work effectively in a cross-cultural environment with individuals having diverse cultural backgrounds.
Understand the basics of pharmaceutical promotion development and review process.
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