Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

GxP & PS Compliance Training Manager

$98.82k - $150k

Merck & Co. Inc

About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference? The Position We are seeking a detail-oriented, technically skilled, and passionate Training Manager to join our GxP Compliance & Patient Safety team at Novo Nordisk. This role is responsible for the strategic oversight, administration, governance, and continuous improvement of Novo Nordisk Inc.'s Learning Management System (LMS). This role ensures the LMS effectively supports enterprise learning initiatives, compliance training requirements, and reporting. The Training Manager serves as the primary business owner for LMS operations, partnering closely with Clinical, Regulatory & Medical (CMR), Information Technology (IT), Sales and other business stakeholders to ensure accuracy in training assignments and reporting. This position is responsible for managing LMS configuration, reporting, and training governance processes while ensuring compliance with applicable regulatory and company requirements. The ideal candidate will possess a strong command of pharmaceutical regulations, clinical research processes, and GxP quality management systems, combined with exceptional organizational skills and an unwavering commitment to maintaining the highest standards in a highly regulated environment. Relationships This position reports to the Associate Director, GxP Compliance & Patient Safety Training. This role will collaborate cross functionally with Patient Safety, Quality Assurance, Vendor and Contract Management, Information Technology (IT), Finance, and Sales. The Training Manager will drive and maintain positive rapport and working relationships within and across departments in relation to accurate assignment of training requirements, required quality and regulatory reporting and end user support. LMS Administration & Operations Serve as the primary administrator supporting NNI on the enterprise LMS. Administer and maintain the LMS for all NNI training programs, ensuring accurate and up-to-date records of participation and completion. Support the deployment and maintenance of training programs, curricula, and certification requirements. Manage training assignments, learner enrollments, completion tracking, and recurring certification processes. Support internal and external stakeholders with issue resolution in a timely fashion and in a manner which meets their expectations. Generate training reports and analytics to monitor completion rates, training effectiveness, and compliance metrics. Establish and maintain LMS governance standards, processes, and documentation. Ensure system compliance with global policies, audit requirements, and applicable regulatory standards. Support audits and compliance reviews by producing accurate and timely training records. D evelop and leverage relationships with HQ SMEs, process management, and system management to influence process and system development in a manner consistent with global / affiliate health authority and/or stakeholder requirements. Provide guidance and/or training to less experienced professionals or support staff. Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs. Curriculum & Assignment Maintenance Implement job specific training curricula tailored to distinct roles within clinical operations, medical affairs, and regulatory affairs. Manage training assignments encompassing clinical research documentation, regulatory requirements, Good Clinical Practice (GCP), and medical affairs procedures. Partner with Curriculum Managers to implement new curricula and manage updates to existing learning programs, ensuring training requirements are accurately assigned and aligned with role-specific, business, and compliance needs. Actively collaborate with SOP team, Content SMEs, and Curriculum Manager to ensure seamless flow of information and documentation from QualityDocs to LMS, as applicable. Alongside SOP team, Content SME, and Curriculum Manager ensure required training is accurately assigned in LMS. Partner with business stakeholders and Curriculum Manager to develop and maintain curriculum assignment standards, ensuring training requirements are consistently and accurately deployed across the organization. Develop, implement, and maintain governance processes and quality controls to ensure learning curricula are accurately assigned based on role, business function, and compliance requirements. Audit, Inspection & Quality Support Support internal audits, external inspections, and regulatory inquiries by providing accurate and timely training records, compliance reports, curriculum assignments, and learner completion documentation. Serve as the LMS subject matter expert during audits and inspections, ensuring training data integrity, traceability, and readiness of training documentation. Partner with Quality, Compliance, and business stakeholders to support deviation investigations by providing training records, assignment histories, completion data, and curriculum documentation as needed for root cause analysis. Support the implementation and tracking of Corrective and Preventive Actions (CAPAs) related to training processes, ensuring required training activities, curriculum updates, and assignment changes are completed, documented, and monitored for effectiveness. Conduct periodic reviews and audits of training assignments and records to identify compliance risks, implement corrective actions, and maintain inspection readiness. Maintain documentation and standard operating procedures related to LMS administration and training governance to support regulatory compliance and audit preparedness. Qualifications Bachelors degree required; relevant experience may be substituted for degree, when appropriate. Requires a minimum of 6 years of progressively responsible, relevant experience; some experience in area of specialty required. Ability to work independently with general direction from own manager. Exercises judgment in selecting methods and approaches to assignment. Can plan, schedule, and arrange own activities in accomplishing objective. Ability to proactively anticipate multiple deadlines, and drive and manage priorities is required. Excellent speaker and/or presentation skills. Well-developed interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment. Excellent project management and organizational skills. The base compensation range for this position is $98,820 to $150,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long‑term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex‑able vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long‑term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. #J-18808-Ljbffr

Vacancy posted 6 hours ago
Similar jobs that could be interesting for youBased on the GxP & PS Compliance Training Manager in Plainsboro, NJ vacancy
  • About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA...
    Suggested

    Novo Nordisk

    Plainsboro, NJ
    3 days ago
  • $122k - $146k

     ...Rocket Pharma in Cranbury Township, NJ, is seeking a Training Manager to oversee its training program designed for compliance and improvement across the company. The ideal candidate will manage training materials, assess needs, and ensure compliance with health authority... 
    Suggested

    Rocket Pharma

    Cranbury, NJ
    4 days ago
  • $122k - $146k

     ...Training Manager Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket...  ...on ensuring the effectiveness and compliance of Rocket's training strategies and requirements...  ...teams to create and deliver other GxP and non-GxP training courses such as... 
    Suggested
    Temporary work
    Work experience placement
    Local area
    Flexible hours
    Shift work

    Rocket Pharmaceuticals

    Cranbury, NJ
    4 days ago
  • $122k - $146k

    A leading biotechnology company in Cranbury Township is looking for a Training Manager to oversee their training program and ensure compliance with health authority guidelines. The role involves creating training materials, administering programs, and collaborating with... 
    Suggested

    Rocket Pharmaceuticals

    Cranbury, NJ
    4 days ago
  • $186.49k - $278.88k

     ...POSITION SUMMARY The Compliance & Business Management (CBM) team supports key Pharmacovigilance (PV) operational...  ...reporting, alliance management, training, SOP governance, and documentation quality...  ..., governance, and execution of GxP regulatory inspections impacting PV,... 
    Suggested
    Contract work
    Temporary work
    Local area
    Worldwide
    Flexible hours
    Shift work

    JobRx, Inc.

    Princeton, NJ
    3 days ago
  • $121.1k - $181.13k

     ...POSITION SUMMARY The Compliance & Business Management (CBM) team supports key Pharmacovigilance operational, compliance, and business activities across...  ...background in pharmaceutical quality system management (GxP). Experience with coordination and/or participation in PV... 
    Contract work
    Temporary work
    Flexible hours

    JobRx, Inc.

    Princeton, NJ
    1 day ago
  • $248k - $310k

     ...authority interactions, product approvals, and lifecycle management globally. This role serves as a key partner to...  ...while maintaining scientific integrity and compliance Ensure that regulatory communications meet GxP, inspection-readiness, and documentation standards... 
    Contract work

    Kardigan

    Princeton, NJ
    16 hours ago
  •  ...Syneos Health in Princeton, NJ is looking for a Training Manager to lead the commercial training strategy. The successful candidate will be responsible for designing, developing, and executing training programs to support product launches and enhance field effectiveness... 
    Part time

    Syneos Health Inc

    Princeton, NJ
    1 day ago
  • $160k

     ...Syneos Health Learning Solutions in Princeton, NJ, is seeking a Training Manager for commercial training strategy design and execution. This role requires strategic leadership and hands-on execution. Candidates must have a BS/BA degree and over 5 years of experience in... 

    Syneos Health Learning Solutions

    Princeton, NJ
    3 days ago
  • $70k - $80k

     ...Job Description Salary: 70,000.00 - 80,000.00 Safety & Compliance Manager Location: Corporate Office (regular presence required)...  ...This role owns the core safety program including OSHA logs, training, investigations, corrective actions, and compliance reporting... 
    Full time
    Work at office

    Total Warehouse Solutions

    Cranbury, NJ
    11 days ago
  • $160k

     ...Description The Training Manager will be an integral part of Syneos Health Learning Solutions team with a primary responsibility...  ...plans and state Medicaid plans ~ Understanding of compliance & privacy laws ~ Demonstrated project management skills... 
    Flexible hours
    3 days per week

    Syneos Health/ inVentiv Health Commercial LLC

    Princeton, NJ
    2 days ago
  •  ...possible and making headway to help improve outcomes. The Manager, Global Trade & Customs Optimization is an individual contributor...  ...impact assessments to reduce landed cost while ensuring full compliance with applicable customs regulations. The position partners... 

    Integra LifeSciences

    Princeton, NJ
    3 days ago
  • Novo Nordisk is looking for a dedicated Training Manager for its GxP Compliance & Patient Safety team. This role involves managing the Learning Management System (LMS) to ensure effective training compliance and reporting within the organization. The ideal candidate should... 

    Merck & Co.

    Plainsboro, NJ
    1 day ago
  • $114.1k - $211.9k

     ...submissions and approvals to support the biosimilar pipeline. Manage high‑quality regulatory documents and track regulatory activities...  ...as preparation of NDC forms, annual reports, etc., to ensure compliance with regulatory health authorities. Determine requirements and... 
    Work at office
    Local area
    Remote work
    Visa sponsorship
    Work visa
    Relocation package
    Flexible hours

    Sandoz

    Princeton, NJ
    3 days ago
  •  ...Initial Therapeutics, Inc. is seeking a strategic compliance advisor to work closely with senior leaders across various functions, including Legal and HR. The ideal candidate will have over 12 years of experience in compliance and legal roles within the life sciences... 

    Initial Therapeutics, Inc.

    Plainsboro, NJ
    3 days ago
  • $243k - $297k

     ...development of Promotion advisory submissions. Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidance....  ...support them in their roles and development. Provide direct management to individuals as required by the assignment. Proactively seek... 
    Flexible hours

    JobRx, Inc.

    Princeton, NJ
    3 days ago
  • $132.48k - $198.72k

     ...experienced and forward‑thinking Senior Manager, Medical, Regulatory and Legal (MeRL) Operations...  .... Develop, maintain, and deliver training materials related to MeRL processes,...  ...pharmaceutical promotional regulations, compliance standards, and submission requirements.... 
    Work at office
    Remote work

    NACBA

    Princeton, NJ
    4 days ago
  •  ...seeking a Regulatory Affairs professional to join their biosimilar team. This role involves supporting the regulatory strategy and managing documentation for product submissions. The ideal candidate should have a Bachelor's degree in a science and 3-5 years of... 
    Remote work
    Flexible hours

    U023 (FCRS = US023) Sandoz Inc

    Princeton, NJ
    4 days ago
  •  ...A leading provider of natural ingredients in New Jersey seeks a Regulatory Manager to oversee day-to-day regulatory operations and ensure compliance across product lines. The role requires a Bachelor's degree in Food Science and 6+ years in the flavor industry. Strong... 

    Vibrant Ingredients

    Cranbury, NJ
    4 days ago
  •  ...negotiations with Health Authorities. Provide on project teams or management committees regulatory expertise/advice on requirements for pre...  ...SOPs / WIs to achieve consistency in regulatory standards and compliance. Assure that all aspects of the Company’s regulatory... 

    Lynkx Staffing LLC

    Princeton, NJ
    11 days ago
  • $224.94k - $272.58k

    Bristol-Myers Squibb in Princeton, NJ is looking for a Senior Director for Global Scientific and Regulatory Documentation. This role involves leading a team of scientific writers to enhance regulatory documentation efficiency and drive innovative initiatives. Candidates...

    Bristol-Myers Squibb Company

    Princeton, NJ
    1 day ago
  • $165k - $220k

     ...Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product...  ...health authority interactions, ensure highquality submissions, and manage regulatory risk across the product lifecycle. Responsibilities... 
    Temporary work
    Work visa

    Bausch + Lomb

    Princeton, NJ
    3 days ago
  • $188.5k - $230k

     ...Director, Regulatory Advertising & Promotion in Princeton, NJ. This role involves providing regulatory advice, ensuring compliance with FDA guidance, and managing internal relationships. The ideal candidate will have an advanced degree and substantial experience in regulatory... 

    Sun Pharmaceutical Industries, Inc.

    Princeton, NJ
    4 days ago
  •  ...Vibrant Ingredients Regulatory Manager Founded in 1954, Vibrant Ingredients is a leading...  ...-to-day regulatory operations, ensure compliance across assigned product lines, support...  ...business needs. Support onboarding, training, and continuous development of regulatory... 

    Vibrant Ingredients

    Cranbury, NJ
    1 day ago
  • $121.1k - $181.13k

     ...JobRx, Inc. is looking for a Manager, GRC Auditor to support the U.S. Ethics & Compliance operational audit program. You will execute audits, provide assurance services, and help detect and prevent fraud. The ideal candidate will have 4 - 7 years of experience in auditing... 

    JobRx, Inc.

    Princeton, NJ
    4 days ago
  • $130k - $150k

     ...Underwriting Training & Development Manager Location: Hamilton Square, NJ or West Hartford, CT (hybrid; 4 days in office, 1 day remote). Berkley...  ...audit process, including guideline adherence, authority compliance, pricing tool usage, and documentation standards. Identify... 
    Work at office
    Remote work

    Berkley Accident and Health (a Berkley Company)

    Hamilton, NJ
    1 day ago
  • $170k - $230k

     ...CSRs, DSURs) to ensure alignment with regulatory strategy and compliance with applicable regulations and guidance Track submission timelines...  ...skills and attention to detail with the ability to manage multiple priorities Effective communication skills and ability... 

    Kardigan

    Princeton, NJ
    16 hours ago
  •  ...degree (MBA, MS, PhD) preferred, PMP preferred; Overview This role supports late-stage drug development programs as a Program Manager working closely with a Program Management Lead and Global Program Team (GPT). The position is highly collaborative and execution-... 
    Work at office

    Net2Source (N2S)

    Princeton, NJ
    4 days ago
  •  ...ACADIA Pharmaceuticals Inc. in Princeton, NJ is seeking a Manager, Data Analytics & Investigations to enhance the healthcare compliance program. The role involves leading analytics projects, conducting audits, and supporting internal investigations, requiring 5+ years... 

    ACADIA Pharmaceuticals

    Princeton, NJ
    3 days ago
  • $160k - $175k

     ...professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global regulatory submissions... 
    Temporary work
    Work at office
    Flexible hours

    Ascendis Pharma A/S

    Princeton, NJ
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to GxP & PS Compliance Training Manager. Be the first to apply!