Regulatory Affairs Specialist jobs in Trenton, NJ
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
C08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALIST
- Eclaro
-
Lawrenceville, NJ
FULL_TIME
-
Pharmacovigilance Specialist
Job Number: (phone number removed)
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Pharmacovigilance Specialist for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
The Pharmacovigilance (PV) Analytics and Reporting Specialist, PV Analytics Center of Excellence is responsible for successful execution, and close-out of activities aligned with the overall vision, strategy, and objectives of the Global Biostatistics & Data Sciences Function.
The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs.
The PV Analytics and Reporting Specialist reports to the Senior Manager, PV Analytics Center of Excellence, within Global Biostatistics & Data Sciences.
The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across WWPS.
Responsibilities:
Data Analytics and Reporting
Build and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making
Maintain and develop reporting databases and analytics applications in environments such as Excel, Tableau, Spotfire, Power BI, SAP Business Objects and/or other Client environments
Leverage internal data systems and tools to efficiently maintain data and reporting processes to minimize manual data retrieving
Liaison with validation team to create validation test script, validation plan, validation summary report and test scripts.
Contribute to qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Pharmacovigilance, Epidemiology, etc.)
Utilize data analysis tools to aggregate and analyze data to make actional recommendations and answer key business questions
Run and maintain reports regarding activities, outcomes, and be prepared to deliver presentations to management team on a regular and ad-hoc basis
Collect data for monthly reports and quarterly reviews regarding activities, outcomes, and trends of the Advisor team
Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our Analytical programs and reporting mechanisms
Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions
Maintain data integrity and traceability across the transformation lifecycle from the Source to Target
Support program and project team activities required to implement innovation initiatives.
Contribute to the management and prioritization of process improvement and innovation initiatives
Define and provide metric reporting and data analysis for GBDS/WWPS initiatives including relevant insights to facilitate decision-making process
Assess and interpret the process impact of new PV tools and processes
Qualifications:
Life Sciences, Information, or similar background (Bachelors, Masters)
5 years Drug Safety/Pharmacovigilance experience
Advanced Tableau, Spotfire, Power BI, SAP Business Objects (BO) skills with 5 years of development experience
Databases (Postgres, Oracle, MS Access, Impala, SharePoint List etc.)
Programming languages (SQL, VBA, Python etc.)
Reporting platforms and services (Cognos, SAP-Business Objects, Power BI etc.)
Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug)
Ability to organize/curate data and see big picture from scattered pieces of information
Knowledge of taxonomies, ontologies, and other knowledge management constructs
Analytical and strategic thinking skills required
Strong PowerPoint, Word, and Excel Skills
Knowledge of Validation processes and associated documentation.
Excellent verbal, writing, presentation, and project management skills
Strong strategic orientation with ability to translate into operational priorities and plans
Ability to promote cooperation and commitment within a team to achieve goals and deliverables.
Ability to resolve complex problems and manage difficult stakeholder situations
Ability to lead the development of critical path analyses and support scenario planning
Promotes and practices effective pro-active decision-making, ensuring timely coordination and dissemination of information
Demonstrated ability to work on multiple projects
Strong willingness to collaborate with cross-functional partners
Flexible, team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
Confidentiality and integrity are required
If hired, you will enjoy the following Eclaro Benefits:
401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya
(phone number removed)
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. - 27 Days Ago
Director, Regulatory Affairs
- Jubilant Pharma Holdings Inc.
-
Yardley, PA
FULL_TIME
- Director of Regulatory Affairs Join Jubilant Radiopharma as our Director of Regulatory Affairs and be at the forefront of revolutionizing healthcare through innovative radiopharmaceuticals. About Us: ...
- 6 Days Ago
Regulatory Affairs Manager
- Ultimate
-
Princeton, NJ
CONTRACTOR
- Job Description Regulatory Affairs Manager Duration: 2 years; possibility of conversion to FTE (not guaranteed)Hourly Pay Rate: $60.00-$63.00/hourExpected Weekly Hours/Schedule: 40 hours Mon thru FriL...
- 11 Days Ago
MANAGER REGULATORY AFFAIRS
- TK-CHAIN LLC
-
Princeton, NJ
FULL_TIME
- SUMMARY OF POSITIONManages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quali...
- 28 Days Ago
DIRECTOR REGULATORY AFFAIRS
- TK-CHAIN LLC
-
Princeton, NJ
FULL_TIME
- SUMMARY OF POSITIONThe Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our...
- 29 Days Ago
Regulatory Publishing Affairs
- Arete Technologies, Inc.
-
Princeton, NJ
FULL_TIME
- Company DescriptionArete Technologies, Inc. offers set of innovative Consulting and Outsourcing services, bridging the gap between requirements and outputs of various dexterous and facile companies wo...
- 1 Month Ago
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0 Regulatory Affairs Specialist jobs found in Trenton, NJ area
USA-Regulatory Affairs Specialist II (Clinical)
- eTeam Inc.
-
Bridgewater, NJ
- Regulatory Affairs Specialist II (Clinical) Bridgewater, NJ-100% Remote 7 Months contract Pay Rate: $45-55/hr on w2 Cand...
- 4/24/2024 12:00:00 AM
CMC Regulatory Affairs Specialist
- Spectraforce Technologies Inc
-
Bridgewater, NJ
- Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shif...
- 4/23/2024 12:00:00 AM
Regulatory Affairs Specialist II
- Katalyst Healthcares & Life Sciences
-
Edison, NJ
- Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical ...
- 4/23/2024 12:00:00 AM
CMC Regulatory Affairs Specialist
- Spectraforce Technologies Inc
-
Bridgewater, NJ
- Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shif...
- 4/23/2024 12:00:00 AM
Regulatory Affairs Specialist Team Lead
- The Fountain Group LLC
-
Bridgewater, NJ
- The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Lead for a prominent Phar...
- 4/23/2024 12:00:00 AM
Lead Regulatory Affairs Specialist
- Globus Medical, Inc.
-
Audubon, PA
- About Us: At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of ...
- 4/22/2024 12:00:00 AM
Senior Regulatory Affairs Specialist
- Bausch + Lomb
-
Bridgewater, NJ
- Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of ...
- 4/21/2024 12:00:00 AM
Regulatory Affairs Specialist Team Lead I (Scientific)
- Pyramid Consulting, Inc
-
Bridgewater, NJ
- Immediate need for a talented Regulatory Affairs Specialist Team Lead I (Scientific). This is a 09+ Months contract oppo...
- 4/20/2024 12:00:00 AM
About Trenton, New Jersey
According to the United States Census Bureau, the city had a total area of 8.155 square miles (21.122 km2), including 7.648 square miles (19.809 km2) of land and 0.507 square mile (1.313 km2) of water (6.21%).
Several bridges across the Delaware River – the Trenton–Morrisville Toll Bridge, Lower Trenton Bridge and Calhoun Street Bridge – connect Trenton to Morrisville, Pennsylvania, all of which are operated by the Delaware River Joint Toll Bridge Commission.
Trenton is located near the exact geographic center of the state, which is 5 miles (8.0 km) located southeast of Trenton. The city is so...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$82,486 to $110,544
Trenton, New Jersey area prices
were up 1.5% from a year ago
were up 1.5% from a year ago
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020