Compliance Analyst

2 weeks ago

Raritan, United States Source One Technical Solutions Full time

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global Pharmaceutical Manufacturing Company. This is fully Remote position, however you may travel for a possible mandatory meeting onsite for 1-2 days, not very often at all.


Job Title: Aggregate Report Compliance

Contract Duration: 12 months, with a potential extension

Location: Raritan, NJ

w2 Hourly Pay Rate Range: $35.00 - $40.00 hourly

40 hours/week, Mon-Fri

Remote


Job Description:

  • Must have Pharmacovigilance and Regulatory experience in pharmaceutical industry supporting the Aggregate Tracking Process.


In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities.


In support of aggregate report compliance, the individual will be responsible for supervising compliance and ensuring appropriate documentation is completed when there are late submissions to Health Authorities.


The Sr. Associate, Aggregate Report Compliance will generate compliance metrics and reports in support of MSQ Compliance and Risk Management key partners, including:


• Office of the Chief Medical Officer (OCMO) Senior Leadership Team

• Office of the QPPV

• Global Regulatory Affairs

• International Pharmacovigilance Leadership

• Other partners across business


Compliance metrics and data produced feed into:


• Quality Management Reviews

• Medical Safety Council Operational Compliance Committees

• Other compliance review venues and for other functional partners


The individual will drive the precision and consistency of compliance metrics and be responsible for ensuring that publication of all standard compliance metrics are completed in a timely, accurate and consistent fashion and will innovate by streamlining processes and driving efficiencies.


Keys for success in this role include the ability to develop partnerships with Global Regulatory Affairs, Local Operating Companies, and strategic vendor colleagues.


Support the aggregate report tracking process and systems

Monitor compliance of aggregate report submissions to Health Authorities and generation of compliance metrics


OTHER DUTIES

The individual, with oversight from the Manager of Aggregate Report Compliance and Vendor Oversight, will be accountable for prioritizing and ensuring that deliverables are completed on time and are accurate and consistent. The individual will follow documented processes and procedures for aggregate report compliance monitoring and metrics generation.


Required Knowledge, Skills and Abilities:


• Knowledge of GxP requirements and experience with safety processing, clinical safety study reporting, PV and medical information preferred

• Ability to function in a global matrix environment

• Excellent communication and writing skills

• Understanding of and experience with multi-cultural working is preferred

• Project Management experience with organizing actions and managing team activities is preferred

• Proficiency in Microsoft Excel and SharePoint is required

• Requires problem-solving skills to interpret and analyze data and information

• Experience in high volume work environment preferred.


Required Minimum Education:

Minimum of Bachelor’s Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 4 years of pharmaceutical industry experience or advanced academic degree with 2 years of pharmaceutical industry experience.


Required Years of Related Experience: Minimum of 2 years of experience in pharmacovigilance case processing, aggregate reporting, and/or PV compliance monitoring.

  • Analyst 2 - Compliance

    2 weeks ago

    Raritan, United States LanceSoft Full time

    Description: Title: Sr. Associate, Aggregate Report Compliance/Compliance Analyst 2 Location: Raritan, NJ - 100% Remote Duration: 1 Year In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance...

  • Compliance Analyst

    2 weeks ago

    Raritan, United States Source One Technical Solutions Full time

    Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global Pharmaceutical Manufacturing Company. This is fully Remote position, however you may travel for a possible mandatory meeting onsite for 1-2 days, not very often at all. Job Title: Aggregate Report...

  • Analyst 2 - Compliance

    2 weeks ago

    Raritan, United States Ampcus Incorporated Full time

    Sr. Associate, Aggregate Report Compliance In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities. In support of aggregate report...

  • Analyst 2 - Compliance

    2 weeks ago

    Raritan, United States Artech Full time

    Sr. Associate, Aggregate Report Compliance In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities. In support of aggregate report...

  • Analyst 2 - Compliance

    4 days ago

    Raritan, United States eTeam Full time

    Sr. Associate, Aggregate Report Compliance In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities. In support of aggregate report...

  • Analyst 2 - Compliance

    6 days ago

    Raritan, United States US Tech Solutions, Inc. Full time

    Sr. Associate, Aggregate Report ComplianceRole can be 100% REMOTE- May travel for a possible mandatory meeting onsite for 1-2 days, not very often at all- Bachelors Degree required- Pharmacovigilance experience needed- Must be flexible / adaptive- Must be able to problem solve, and know when to ask for help- Working within the Global Environment / Global...

  • Analyst 2 - Compliance

    6 days ago

    Raritan, United States US Tech Solutions Full time

    Sr. Associate, Aggregate Report Compliance Role can be 100% REMOTE - May travel for a possible mandatory meeting onsite for 1-2 days, not very often at all - Bachelors Degree required - Pharmacovigilance experience needed - Must be flexible / adaptive - Must be able to problem solve, and know when to ask for help - Working within the Global Environment /...

  • Contract Validation Analyst

    2 days ago

    Raritan, United States QuidelOrtho Full time

    The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers...

  • Chargeback Analyst

    22 hours ago

    Raritan, United States Johnson & Johnson Full time

    Johnson & Johnson Health Care Systems, Inc. is recruiting for a Chargeback Analyst-Enterprise Contract Management (ECM), to be located in Raritan, NJ! Johnson & Johnson Health Care Systems Inc. (JJHCS) provides contracting, supply chain, business services, and strategic solutions to customers and commercial intermediaries of U.S.based Johnson & Johnson...

  • Analyst 3 - Financial Planning/Analysis

    3 days ago

    Raritan, United States Pioneer Data Systems Full time

    Position Details: Our client, a world-leading Pharmaceutical Company in Raritan, NJ or Titusville, NJ is currently looking for a Financial Analyst II to join their expanding team. Job Title: Financial Analyst II / SAP FICO Duration: 9 month contract extendable up to 24 Months Location: Raritan, NJ or Titusville, NJ Note: The client has the...

  • Senior Analyst, Government Rebate Operations

    3 weeks ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson Health Care Systems Inc. (JJHCS), a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Analyst, Government Rebate Operations (GRO) Contracts to support our Enterprise Contract Management (ECM) team, to be located in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in...

  • Global Oncology R&D and Commercial Finance Manager

    6 days ago

    Raritan, United States Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for Finance Manager, Global Oncology R&D and Commercial, Heme DAS. This position can be based in New Jersey (Raritan, Titusville) or Pennsylvania (Spring House) and may require up to 10% domestic travel. At Johnson & Johnson what matters most is helping people live full and healthy lives. We focus on...

  • Global Oncology R&D and Commercial Finance Manager

    6 days ago

    Raritan, United States Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for Finance Manager, Global Oncology R&D and Commercial, Heme DAS. This position can be based in New Jersey (Raritan, Titusville) or Pennsylvania (Spring House) and may require up to 10% domestic travel. At Johnson & Johnson what matters most is helping people live full and healthy lives. We focus on...

  • Analyst 4 - Information Security

    3 weeks ago

    Raritan, United States Mindlance Full time

    Title - Application Security Manager We are seeking an Information Security and Compliance consultant with experience in providing security applications controls and assessments for pharmaceutical Manufacturers located in Raritan, NJ. As a Cyber Security Analist , this resource will work within the Information Security and risk Management department, joining...

  • Manager, Managed Markets Contract Ops

    4 weeks ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson Health Care Systems Inc. (JJHCS) is currently recruiting for a Manager, Managed Markets & Specialty Contract Operations, in the Enterprise Contract Management (ECM) organization, located at Raritan, NJ At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex...

  • Technology Services

    2 weeks ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson is recruiting for a Technology Services - Senior Manager, SAP Finance who is passionate about developing sophisticated solutions and providing technical and process expertise to support Finance requirements. The position is to be located in Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the...