-
IACUC Regulatory Compliance Specialist
1 day ago
Partners Healthcare System Charlestown, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Leads the investigation, ...
-
IACUC Regulatory Compliance Specialist
2 days ago
Massachusetts General Hospital(MGH) Charlestown, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Leads the investigation ...
-
Regulatory and Compliance Manager
1 week ago
Harvard University Cambridge, United States Full timeRegulatory and Compliance Manager · Harvard T.H. Chan School of Public Health · 65363BR · Job Summary · The Pediatric HIV/AIDS Cohort Study (PHACS) network conducts several longitudinal cohort studies investigating the long-term effects of exposure to HIV and ARV (antiretroviral) ...
-
Gradient Boston, United StatesJob Description · Job DescriptionGradient, an environmental consulting firm, is seeking a high energy individual to assist colleagues and clients by applying knowledge of US and international regulatory compliance for product stewardship. Responsibilities include providing regula ...
-
Quality and Regulatory Compliance Manager
1 week ago
Katalyst HealthCares & Life Sciences Framingham, United StatesResponsibilities: Ensure compliance with quality standards and regulatory requirements for products subcontracted to external entities, adhering to cGMPs and quality directives. · Oversee the efficiency of the Quality System implemented between the company and subcontractors, m ...
-
Regulatory Payments Compliance Director
2 weeks ago
BlueSnap Waltham, United StatesBlueSnap is a rapid growth international FinTech company, headquartered in Waltham, MA, with offices in Israel, Ireland, and the UK. We are thrilled to be one of the fastest growing companies in the payments industry. Our team works collaboratively building a world-class all-in-o ...
-
Staples Framingham, United StatesLead the global quality function for private brands, including quality assurance, quality control, and post launch product quality Act as the executive sponsor and commercial relationship owner for Staples' 3rd party audit, testing and inspection ser Compliance, Regulatory, Produ ...
-
Olympus Corporation of the Americas Westborough, United StatesWorking Location: PENNSYLVANIA, CENTER VALLEY · Workplace Flexibility: Hybrid · Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. · Olympus, a leading medical technology company, has focused on m ...
-
Program Manager: II
1 week ago
Dexian Brookline, United StatesDescription: · Support the definition of the EPMO documentation including standards, processes and guidance to guide the project management and SDLC functions · Responsibilities: · Lead IPMM tollgate compliance, partnering with entity level PMOs; evolve methodology to support eme ...
-
Brigham and Women's Hospital Brookline, United States Full timePHYSICAL THERAPIST, AMBULATORY- CHESTNUT HILL, MA Description STAFF PHYSICAL THERAPIST PT/ AMBULATORY CARE / FULL TIME/ 40 HOURS / CHESTNUT HILL, MA · Ask about our New Salary range -- starts at 90K · Excellent Benefits: Generous Paid Time Off, 403B Match, Pension/Cash Balanc ...
-
Compliance and Process Technology Expert
1 week ago
Phoenix Innovations Logan, United StatesJOB DESCRIPTION · Welcome to the Solids Launch Factory, the beating heart of our pharmaceutical production. Here, we bring all new tablet-based drug launches to global market readiness and ensure initial market supply. With our lived start-up mentality, we drive modern processes ...
-
Sr. Director of Regulatory Affairs
4 weeks ago
Accordance Search Group Cambridge, United StatesWhat this position is all about: We are looking for a strategic and results-driven Head of Regulatory Affairs (level commensurate with experience) to lead our regulatory efforts and activities for the advancement of our assets through early clinical development. This individual w ...
-
Regulatory Affairs Specialist
2 weeks ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
-
Senior IT Risk
1 week ago
Eclipse Innovations Milton, United StatesJoin the JobRad success story and apply now · We may not have reinvented the wheel, but we have revolutionized company bicycles. · JobRad is the market and quality leader in the booming bike leasing industry. · At our headquarters in Freiburg and in our field sales throughout Ger ...
-
Associate Director/Director, GMP QA
1 week ago
Leap Therapeutics Cambridge, United StatesCompany Summary: · · Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in p ...
-
Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
-
Program Management Office Lead
1 week ago
QurAlis Cambridge, United StatesTitle: Program Team Lead (Director/Sr. Director) · ABOUT THE COMPANY · At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medic ...
-
Clinical Operations Analyst
1 week ago
Medasource Cambridge, United States ContractApply Now · << Clinical Operations Analyst · Boston, Massachusetts (Hybrid) · 1 year contract with likelihood of extension · Project Goal & Overview: · Our client is seeking a highly experienced Senior Clinical Analyst to lead and execute enterprise initiatives for clinical opera ...
-
Senior Compliance Auditor
2 weeks ago
EPM Scientific Cambridge, United StatesSenior Compliance AuditorRole Description:Oversee and participate in audits, reporting on findings.Manage Quality Technical Agreements with critical suppliers.Conduct internal audits to meet GMPs, 820 standards, and company requirements.Lead and support supplier audits (onsite an ...
-
QA Specialist
1 week ago
LanceSoft Cambridge, United StatesPOSITION TITLE: QA SpecialistDURATION: 1 YEARSHIFT: 2nd shift- 3pm - 11pm Monday through Friday100% ON SITEWe are seeking a highly skilled and experienced Senior QA Specialist to join our dynamic team. In this role, you will be responsible for overseeing the quality assurance pro ...
Program Manager, Clinical Regulatory Compliance - Brookline, United States - Dana-Farber Cancer Institute
Description
The Program Manager, Clinical Regulatory Compliance & Accreditation works directly with staff, management, and senior leadership to coordinate and perform day-to-day activities related to regulatory compliance across all Dana-Farber sites.
The Program Manager, Clinical Regulatory Compliance & Accreditation will also play a critical role in leading Dana-Farber's regulatory steering committee.
Under the supervision of the Senior Director for Quality Assurance and Regulatory Compliance, the Program Manager, Clinical Regulatory Compliance & Accreditation will support various initiatives in the areas of clinical regulatory compliance.
Examples include data analysis and reports to meet the regulatory requirements of The Joint Commission (TJC), Department of Public Health (DPH), and the Centers for Medicare and Medicaid Services (CMS).
This role will collaborate with the leaders of committees and task forces at Dana-Farber, Brigham & Women's Hospital, and Boston Children's Hospital, to assure coordination and consistent documentation of regulatory action plans and follow-up activity.
As a key member of the Quality Assurance and Regulatory Compliance team, this role will support the regulatory needs of Dana-Farber's new inpatient cancer hospital and new collaboration with Beth Israel Deaconess Medical Center as that work ramps up.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care.
We are united in our mission of conquering cancer, HIV/AIDS and related diseases.We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.
We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
This position's work location is hybrid with two or three days per week remote. The selected candidate may only work remote days from a New England state (ME, VT, NH, MA, CT, RI).
Leads technical support for regulatory and accreditation compliance, including coordination of Joint Commission survey readiness (pre- and post-survey follow up), shepherding action plans associated with the submission of the Focused Standards Assessment tool, and conducting related educational programs and tracers in our clinical locations.
In collaboration with the Senior Director, coordinates Dana-Farber's regulatory steering committee – the Continuous Readiness Leadership (CRL) Committee.
Evaluates the impact of new regulatory requirements as they are released and prepares summaries, recommendations, and actions plans as relevant.
Directs implementation of new regulatory requirements and surveys as they arise, actively supporting staff throughout the Institute.Compiles Joint Commission readiness reports to keep senior leadership informed at all times. Presents data and analyses to key stakeholder groups independently, as requested.
Staffs and attends various ad-hoc and standing committees to ensure support, discussion, documentation, and general awareness of current, emerging, and other regulatory changes.
Implements and maintains a system to notify staff and leadership of current and upcoming regulatory changes from The Joint Commission and other agencies.
Prepares regulatory readiness summaries and recommendations for prioritization of decisions to Dana-Farber leadership.Coordinates and leads formal education programs to a wide variety of stakeholders across Dana-Farber regarding compliance expectations, feedback on readiness efforts, strategies for success, and communication plans.
Manages development of tools, learning aids, standard reports, and monitoring plans to promote compliance with all regulatory standards. Conducts ongoing tracing activities and document reviews.Acts as liaison to various departments within Dana-Farber – inclusive of our inpatient hospital and all ambulatory sites across our main and regional campuses – to ensure continuous regulatory readiness.
Maintains relevant project data and conducts related analyses, pulling results into meaningful reports and presentations as needed.Performs routine audits of records and observes workflows to ensure compliance with policies.
In collaboration with inpatient hospital leadership, ensures timely review of all inpatient hospital policies.
Occasional travel required to regional campuses in the greater Boston area to evaluate regulatory readiness and provide educational opportunities to frontline staff.
Performs all other related duties as required.Bachelor's degree required; Master's degree in healthcare administration/management, public health, or other relevant field of study preferred.
3 years of experience in a healthcare organization required; preferably in a related position.
Proficiency in IBM PC systems and applications including Excel, PowerPoint, and other database management software required.
Data management and analytic system experience preferred.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Knowledge of current issues in the healthcare environment preferred, particularly regarding quality measurement, regulatory compliance, and patient safety
Demonstrated project management skills and experience
Excellent organizational skills with a strong focus upon managing details
Exceptional written and oral communication abilities
Strong analytical and critical thinking skills
Ability to anticipate and make correct decisions in a fast-paced, dynamic environment
Ability to focus on multiple projects and re-establish priorities as necessary
Ability to work effectively with clinical, operational, and IT staff at all levels of the organization
Desire and ability to train and mentor team members
Ability to facilitate and work within a complex, multi-site environment.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.
As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.
Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
EEOC Poster#J-18808-Ljbffr
&v=024){kind=logo}
