- Development and management of Integrated Quality Plans (IQPs)
- Work with risk and mitigation owners to control risks identified in the IQP
- Provide input into compound and trial strategies to ensure risks are identified and mitigated early
- Lead Quality Working Group meetings (QWGs) to define and refine the IQP
- Lead the escalation of and resolution of significant quality issues
- Lead inspection readiness activities, manage site inspections and assist in the facilitation of Sponsor Monitor inspections
- Act as CRM single point of contact for cross-functional and clinical trial teams and provide support on GCP/quality issues
- Conduct quality reviews of documents, as required
- Conduct ad hoc quality checks of trial TMFs
- As required, support the quality integration of post-licensing and acquisition assets
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Biogen Cambridge, United StatesAbout This Role. The Associate Director, Enterprise Risk Management (ERM) plays a crucial role in overseeing the organizations overall risk management profile. Leveraging your in- depth biotech/pharmaceutical expertise, you will identify, assess, mi Risk, Director, Management, En ...
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Biogen Cambridge, United StatesJob Description · About This Role · The Associate Director, Enterprise Risk Management (ERM) plays a crucial role in overseeing the organization's overall risk management strategy. This individual plays a critical role to identify, assess, mitigate, and monitor risks that could i ...
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Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · About This Role · The Associate Director, Enterprise Risk Management (ERM) plays a crucial role in overseeing the organization's overall risk management strategy. This individual plays a critical role to identify, assess, mitigat ...
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Risk Manager
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IASIS Healthcare Brighton, United StatesRisk ManagerClick Here to Apply OnlineJob DescriptionLocation: St. Elizabeth's Medical CenterPosted Date: 3/5/2024Job Type: Full TimeDepartment: SEH Quality & SafetyRisk ManagerFull Time, Day Shift, 40 hours/wk, Mon -Fri 8:00am - 4:00pm, no weekends or holidays We are fighting fo ...
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EY Boston, United StatesEY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the b ...
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Information Technology Boston, United StatesJob Description · Job DescriptionCybersecurity Risk Management Technical Lead - Technology Risk Management · Overview: · The Cybersecurity Risk Management Technical Lead oversees the Financial Institution's affiliated Investment Managers in the America, acting as the second line ...
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Morgan Stanley Boston, United StatesMSIM Non-Financial Risk Management – Senior Associate Job Number: · Posting Date · :May 9, 2024 Primary Location · :Americas-United States of America-Massachusetts-Boston Job · :Asset/Investment ManagementEmployment Type:Full TimeJob Level:Senior Associate Description ...
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Takeda Development Center Americas, Inc Cambridge, United StatesTakeda Development Center Americas, Inc. is seeking a Director, PV Risk · Management in Cambridge, MA to provide global strategic leadership and expertise in risk management across therapeutic areas. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the U ...
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Investment Risk Manager
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Wellington Management Boston, United StatesAbout Us · Wellington Management offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return and risk objectives of institutional clients in more than 60 countries, dr ...
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Director of Risk Management
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Massachusetts Bay Transportation Authority Boston, United States**Salary** · - $114, $140,000.00 Annually**Location** · - 10 Park Plaza, Boston**Job Type** · - Full-Time**Job Number** · **Department** · - MBTA - Treasurer Controller**Area** · - 719-Tres Controller Finance**Opening Date** · - 04/27/2024**Closing Date** · - 5/13/2024 11:59 PM E ...
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Director, PV Risk Management
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Takeda Development Center Americas, Inc Cambridge, United StatesTakeda Development Center Americas, Inc. is seeking a Director, PV Risk · Management in Cambridge, MA to provide global strategic leadership and expertise in risk management across therapeutic areas. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the U ...
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Universal Health Services Brookline, United StatesDirector of Risk Management & Performance Improvement - HRI Hospital is 66-bed psychiatric facility with adult inpatient services and several partial hospitalization programs. We are part of the largest private mental health system in Massachusetts a Risk, Director, Performance, ...
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MassMutual Boston, United States Full timeRisk Manager, Procurement Shared Services · Full-Time, · Boston, MA or Springfield, MA · The Opportunity · As a Procurement Risk Manager, we need your experience and leadership to partner closely with teams in the MassMutual's Procurement Organization and cross-functional stakeho ...
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Procurement Risk Manager
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MASSMUTUAL Boston, United States**Risk Manager, Procurement Shared Services** · **Full-Time,** · **Boston, MA or Springfield, MA** · **The Opportunity** · As a Procurement Risk Manager, we need your experience and leadership to partner closely with teams in the MassMutual's Procurement Organization and cross-fu ...
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SC Staffing, Inc. Boston, United StatesPosition: Director of Risk Management · Department: Risk Management · Schedule: Full Time · The Director of Risk Management oversees the operation of the Risk Management and Patient Safety programs and provides guidance to clinical staff. The Director will develop and maintain s ...
Oncology Risk Manager - Somerville, United States - Johnson & Johnson
Description
Janssen Reseach and Development LLC is recruiting for an Oncology Risk Manager, located in Spring House, PA, Beerse, Belgium, Madrid, Spain, Issy Les Moulineaux, France, High Wycome, Great Britain, Malvern, PA, Wayne, PA, Somerville, NJ, Horsham, PA, Raritan, NJ or Titusville, NJAt Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at
The MANAGER (ONC Risk Management) works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well - being, or rights.
Throughout the duration of the trial/program, this MANAGER executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.
Key Responsibilities:
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