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Regulatory Affairs Specialist III
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PSG Global Solutions Bridgewater, United StatesWe're looking for a Regulatory Affairs Specialist III , working in Pharmaceuticals and Medical Products industry in Bridgewater, New Jersey, United States .Contributes to the development and oversees the successfulimplementation of regulatory strategies for assigned products, inc ...
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regulatory affairs specialist iii
1 week ago
TE Connectivity PLYMOUTH, United StatesAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. · · Job Overview · Regulatory Affairs oversees compliance activities for customers. This covers reporting, tracking and i ...
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Department of Youth Services Boston, United States**Duties and Responsibilities (these duties are a general summary and not all inclusive)**: · - Ensure proper security, control, and supervision of shift as well as all unit policies, rules and regulations are followed. · - Supervise up to six (6) direct-report staff as well as d ...
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Facilities - Team Leader - Plymouth - Ft
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Atrius Health Plymouth, United States**Facilities - Team Leader - Plymouth - FT** · Atrius Health, an innovative healthcare leader, delivers an effective system of connected care for more than 690,000 adult and pediatric patients at 30 medical practice locations in eastern Massachusetts. Atrius Health's 645 physicia ...
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Billing Specialist III
1 week ago
East Boston Neighborhood Health Center Boston, United States Full timeDescription: · The Billing Specialist III is responsible for organizing work flow to complete the timely and accurate submission of medical and dental claims to Medicaid, Medicare, other third party payors and patients. This position is consistently learning how to better utiliz ...
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Billing Specialist III
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East Boston Neighborhood Health Center Boston, United States Full timeBilling Specialist III · East Boston, MA · Full-time, benefit eligible · The Billing Specialist III is responsible for organizing work flow to complete the timely and accurate submission of medical and dental claims to Medicaid, Medicare, other third party payors and patients. Th ...
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Compliance Specialist III
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Agricultural Specialist III
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Virginia Cooperative Extension Blackstone, United States StaffJob Description · This position is located off campus at the Southern Piedmont Agricultural Research and Extension Center (SPAREC) in Blackstone, Virginia. The successful candidate will generate, collect, analyze, and transfer research data; manage these efforts, plus daily field ...
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Behavioral Health Specialist III
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Lifespan Corporation East Providence, United StatesSummary: · Under the direction of Clinical Nurse Manager (Inpatient)/Program Director (Partial) and Unit Charge RN the Behavioral Health Specialist III (BHS III) is responsible for providing care and safety to children and adolescents as a member of the interdisciplinary treatmen ...
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Behavioral Health Specialist III
1 week ago
Lifespan Corporation East Providence, United StatesSummary: · Under the direction of Clinical Nurse Manager (Inpatient)/Program Director (Partial) and Unit Charge RN the Behavioral Health Specialist III (BHS III) is responsible for providing care and safety to children and adolescents as a member of the interdisciplinary treatmen ...
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Regulatory Affairs Specialist III
1 week ago
eTeam Mansfield, United StatesRemote · Description: · 1) Independently provide EU regulatory requirements and guidance to EU MDR project teams. · 2) Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for C ...
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Community Habilitation Specialist
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SCO Family of Services Holbrook, United States**PURPOSE OF THE POSITION**: Community Habilitation Specialist will provide assessment, skills building training and assistance to individuals with developmental disabilities enrolled in HCBS Waiver living at home to gain skills for independence and to complete documentation in c ...
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Procurement/Sourcing Specialist III
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Thermo Fisher Scientific Plainville, United States**Job Description** · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, a ...
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Procurement/Sourcing Specialist III
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Thermo Fisher Scientific Plainville, United States OTHERJob Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and ...
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Procurement/Sourcing Specialist III
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Thermo Fisher Scientific Plainville, United StatesJob Description · As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and ...
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ESG Specialist III-IV
1 week ago
Avecia Biologics Limited Milford, United StatesAbout this opportunity : · This position, based in Milford, MA, reports to the Director of Environmental, Health and Safety (EHS), and executes hands-on Environmental, Social and Governance (ESG) program coordination, providing education and tools to employees and managers as req ...
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Revenue Cycle Specialist III
1 week ago
East Boston Neighborhood Health Center East Boston, United StatesThank you for your interest in careers at EBNHC · Everywhere you turn, you can feel it. There's an immeasurable level of enthusiasm at East Boston Neighborhood Health Center (EBNHC), one of the largest community health centers in the country. From the nurses and physicians on th ...
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Revenue Cycle Specialist III
6 days ago
East Boston Neighborhood Health Center Boston, United States Part timeRevenue Cycle Specialist III · Remote, Part-time · Are you an experienced Revenue Cycle Specialist seeking to work part time remotely? Reporting directly to department manager and under the general direction of the Lead Biller, the EBNHC Revenue Cycle Specialist performs a wide s ...
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Revenue Cycle Specialist III
6 days ago
East Boston Neighborhood Health Center Boston, United States Full timeRevenue Cycle Specialist III · East Boston, MA · Full-time, benefit eligible · Reporting directly to department manager and under the general direction of the Lead Biller, the EBNHC Revenue Cycle Specialist performs a wide spectrum of billing functions to minimize accounts recei ...
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Revenue Cycle Specialist III
1 week ago
East Boston Neighborhood Health Center Boston, United States Part timeDescription: · Are you an experienced Revenue Cycle Specialist seeking to work part time remotely? Reporting directly to department manager and under the general direction of the Lead Biller, the EBNHC Revenue Cycle Specialist performs a wide spectrum of billing functions to min ...
Regulatory Affairs Specialist III #: - Bridgewater, United States - HireTalent group
Description
Job Title - Regulatory Affairs Specialist IIILocation - Bridgewater, NJ
Duration - 9 Months
Job Description
Manager will consider candidates to be based in either Bridgewater, New Jersey or Cambridge, Massachusetts. Please specify on resume which location candidate is being submitted for.
Preparing, compiling, reviewing and processing the regulatory submissions documents including both pre-approval and submissions such as IND, NDA/BLA, MAA, amendments/supplements, annual reports, etc.
Coordinating and consulting with other concerned functions on the content, and assembly of regulatory documentation and ensuring consistency, completeness and adherence to standards for all the regulatory submissions.
Assist with regulatory communications with the FDA for assigned products and activities, including preparing and formatting of FDA meeting requests, briefing book, meeting rehearsals/slides, meeting minutes of the FDA meetings and the generation of responses to the FDA queries.
Support the compilation, development, submission, and maintenance of worldwide regulatory filings;Track regulatory project status and informational documents
Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
Good oral and written communication skills
Experience with Veeva electronic document management system
Project management skills, including but not limited to creation of timelines, organization of meetings, meeting minutes, demonstrated record of coordinating across stakeholders in a matrixed organization.
Formatting of Microsoft Word templatesFamiliarity with pharmaceutical regulatory affairs.
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