Lead, Evidence Generation Operations応募 後で応募 求人ID R0011480 掲載日 08/29/2019 Location:Boston, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead, GMA (Global Medical Affairs) Evidence Generation Operations in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The objective and purpose of the Lead Evidence Generation Operations, position is as follows:
Supports the review, approval and reporting of Medical Affairs Research programs/projects (i.e. MACs, IIR, CCR) which may be local, regional or global.
Responsible for supporting and reporting of MA studies globally, regionally and locally, in accordance with all applicable internal legal and compliance policies.
Manage cross-functional team (internal and external) to ensure compliance with Takeda policies).
Directly interface and collaborate with internal MA, QA, PV, Regulatory, Legal and IP as it relates to global, regional and local MA research activities.
MA research program, global, regional and LOC support as required may include (budget planning and management, drug supply management, study tracking and archiving, systems development, SOP development, and training).
- Ensures alignment of MA studies, processes and systems with key partners including regional and local offices IP, Regulatory, Legal, OEC, IT, and Finance. Coordinates with regional Pharmacovigilance and Regulatory Affairs leads to respond to external audits and requests from external regulatory bodies. Oversee and coordinate support for internal and external audits related to the MA Research program.
- Provide strategic and functional input to the development of regional MA research plans and budgets in collaboration with MA Region heads, LOC medical leads, TA Medical Heads, alliance partners, and other internal Takeda stakeholders.
- Supervise, direct, coach, and develop MA Research managers and region-based MA research personnel.
- Oversee the tracking and communication of key outputs, performance metrics, and accomplishments related to GMA research. Oversee the appropriate disclosure of study related information in accordance with compliance regulations.
DIMENSIONS AND ASPECTS
Aware of the changing external and internal environment and leads others through change by supporting, inspiring and engaging workplace
Effectively represent Takeda with the ability to resolve conflict in a constructive manner
Ability to build strong partnerships with other interfacing Takeda functions
Able to implement organizational change and continuous innovation
- Knowledge required across therapeutic areas, indications, and/or modalities
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
- Masters of Science or higher degree with 8 years or bachelor degree with 12 years of research related experience in the healthcare, pharmaceutical or related industry.
- Minimum of 2 years management experience.
- Proven track record of strategic leadership, teamwork, innovation, program oversight and demonstrated ability to manage, lead and mentor individuals.
- Demonstrated understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of types of research trials in the pharmaceutical industry.
·Experience working in a global organization highly desirable.
- Experience working in a matrixed environment highly desirable
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)
- Ability to sit for long periods of time
- Carrying, handling, and reaching for objects
- Ability to drive or fly to various internal and external meetings.
- Required travel approximately (10 - 20%), including international trips, overnight stays, and some weekend commitments.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement 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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.