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, Business Operations Analyst - VEEVA Systems Lead for our Global Regulatory Affairs team In our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Business Operations Analyst - VEEVA Systems- Lead in the Global Regulatory Affairs team, you will establish the overall vision with the relevant IT key stakeholders and work with developers to ensure the Electronic Approval System (EAS) and Digital Asset Management (DAM) capabilities form an integrated part of the overall end to end solution in support of the Business Units (BU’s). A typical day will include:
Identify the Digital Strategy and Tool/Feature assessments of the EAS; define innovative process & system solutions, according to business insights and requirements, future needs & operational excellence standards.
Work closely with the IA&P Head of Operations, IT, Patient Value & Product Strategy (PVPS), Oncology BU, Vaccines BU and other relevant functions to provide SME input on the existing EAS and to define the technical roadmap for the future.
Act as an Subject Matter Expert (SME) for release management patches/versions, availability forecasting and change control implementation in the EAS, whilst driving overall guidance to external vendors for the support of system Validation and Training.
Develop and retain relationships through excellent stakeholder management, in the appropriate BU’s with regards to EAS needs requirements and identifying areas for new development.
Main point of contact with the technical vendors and librarian function to define requirements and technical roadmap.
Provide expert integration planning & implementation for the business. This role will be a key stakeholder in concept development sessions, providing expert guidance, identifying areas of possible innovation & harmonization.
Assess & support operational excellence improvements in Standard Operating Procedures and system requirement documentation.
Own the DAM capabilities and dedicated Brand Portals to drive consistent use of promotional and disease awareness activities across the global BU’s; develops same, to support the changing needs of the business.
Provide insights on campaign acceptance to the BU leadership.
Monitor and evaluate industry trends and customer drivers and meet regularly with management and stakeholders to discuss strategy.
Generate new leads, identify and contact decision-makers, screen potential business opportunities, select the deals in line with strategies, lead and facilitate pitch logistics.
Provide support to the global BU’s as EAS SME for system development and in the case of audit.
Supports the development of self and the team in line with the IA&P Head of Operations to ensure consistent alignment on systems across the organisation.
Mentor and develops the capabilities of the IA&P Intern.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelor Degree or above
7+ years technical experience in Electronic Approval System/s for the Healthcare/Pharmaceutical industry
7+ years experience in successful technical project delivery & operational effectiveness (ideally in IT/Integration/Business Operations projects)
4+ years experience working in drug, biologic, device, Regulatory Affairs or related field or equivalent from another highly regulated industry
Experience / Knowledge of VEEVA/Cloud Systems and Platforms.
Strong analytical skills: working knowledge of business needs assessments, business case proposals
Considerable knowledge of change management & dealing with complex and dynamic business environments, including integration projects
Good working knowledge of Global copyright laws/Data Privacy Legislation/Software Licensing Restriction
Ability to understand operational processes, EFPIA and International (ex-US) regulation basics on advertising and promotion for prescription products/basics in pharmaceutical promotion development
Excellent English verbal and written communication skills, fluency in another European language beneficial
International travel may be required (Up to 20%)
Ability to attend offsite meetings that may involve overnight stay
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days