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 a Sr Manager, GRA Compliance in our Deerfield office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a title Sr Manager, GRA Compliance working on the Global Regulatory Affairs team, you will be empowered to be strategic and innovative, and a typical day will include:
The Sr. Manager/Associate Director GRA Compliance is an experienced cross-functional regulatory professional and is accountable for the overall identification, execution and implementation of GRA compliance related activities. S/he will:
Provide leadership and expertise in the identification, creation, and execution of GRA Compliance initiatives to drive overall compliance and growth, while meeting Takeda corporate objectives.
Partners effectively with cross functional teams, in the proactive identification of key regulatory compliance issues with the ability to determine actionable project proposals and drive them to successful resolution.
Provides Global Regulatory Compliance expertise in the development and maintenance of key compliance activities (e.g. labelling, CMC, and/or change control across Takeda.
Align GRA initiatives and implementation strategies with relevant stakeholders which may include Takeda Global Manufacturing, Global Quality and Commercial organizations.
Evaluate and effectively communicate to key stakeholders GRA Compliance program results, identification of program and regulatory risks, risk mitigation and resolution strategies
Responsible for development and execution of GRA Compliance initiatives assigned by leading and overseeing the work of multi-disciplinary, global teams, budget, and risk mitigation strategies to support GRA.
Evaluate GRA processes utilizing industry risk assessment tools and identify opportunities to mitigate compliance risk.
Develops and executes projects and initiatives to mitigate GRA risks through the creation of project business cases, development plans, identifying overall objectives and strategies with timelines and milestones.
Manages cross functional teams and Takeda 3rd party contractors, as necessary, in the execution of project plans, deliverables and implementation of resolutions to ensure compliant GRA processes.
Interacts with all levels of GRA Management to present risks, strategies and project resolutions for assigned compliance activities.
Provides overall project governance in the performance of project escalation resolution
Identifies and integrates project management best practices into the Takeda/GRA business processes to ensure delivery aligned with company initiatives and expectations
Develops strong partnerships with cross functional leadership and third parties to optimize delivery for programs and projects.
Actively and consistently engages in efforts to simplify and optimize business processes and platforms to drive growth
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
Minimum BS/BA degree
7-10+ (Sr Mgr./AD) years of relevant Pharmaceutical business experience within Regulatory and/or Quality required
Expert project management skills
Strong ability to present value proposition and influence change
Communicates complex issues in a clear and concise manner - verbal, written
Works cross functionally across all areas in the organization and with all levels of management and staff.
Good influencing skills to drive business and process change across multiple sites and functions.
Knowledge of global regulatory processes within drug development and regulatory maintenance
Experience in operating in a multi-disciplinary pharmaceutical, complex organization at all levels, including international exposure
Strong leadership capability in developing team environments, motivating and influencing people where the person may not have direct authority
Self-motivated and driven to identify opportunities for this role
Ability to identify risk and determine appropriate risk mitigations
Excellent communicator with strong written and verbal presentation skills
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
Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.