Company

BiospaceSee more

addressAddressPlainsboro, NJ
type Form of workFull time
CategoryAccounting/Finance

Job description

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 health-care-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

Drive and implement NAO Patient Safety strategy specific to creating, setting direction, team integration for Novo Nordisk (NN) Hub locations (India and Mexico). Resource planning and prioritizing department tasks to ensure optimal and flexible use of resources, monitor, and report affiliate support team's performance. Ensure efficient, open, and frequent interaction and communication with stakeholders. Maintain a network within different departments of Global Safety, Novo Nordisk Inc. (NNI) Patient Safety, and outside of Global Safety. Maintains alignment between all case processing units for NAO Patient Safety.

 

Relationships

Reports to the Executive Director, NAO Patient Safety with cross-functional working relationships within Medical, Regulatory, Marketing, QA, Legal and IT. This person will provide direct guidance to a team. This position works closely with counterparts in the Global Safety Departments, including Safety Operations, And Global Service Center.

 

Essential Functions

  • Resource Planning and Performance Monitoring:
  • Establish, maintain, and develop efficient processes for North America safety case handling in close collaboration with NAO PS Management, HQ departments and Safety Global Business Services (GS-GBS) to ensure compliance with regulatory requirements
  • Ensure coordination of activities and perform resource planning for NNI case processing  and NNCI affiliate processing
  • Monitor performance, including regulatory compliance by applying relevant metrics and inform the Executive Director, NAO PS
  • Monitor Internal workflow timelines by applying relevant metrics and ensure that department KPIs are met
  • Ensure optimal and flexible use of resources in the group, including timely identification and resolution of resource gaps
  • Secure cross-organizational collaboration with all relevant stakeholders daily and ensure the adoption of a global mindset
  • Quality & Compliance:
  • Ensure the department’s time and quality compliance concerning case handling on Novo Nordisk products and devices
  • Ensure development and maintenance of departmental and functional procedures and processes related to the collection and reporting of safety data to ensure regulatory compliance
  • Prepare, and participate in audits and Inspections
  • Assure compliance with Novo Nordisk Quality system and business ethics
  • People Management:
  • Recruit staff and request staff in support of PS resource planning
  • Develop, support, and coach for people management roles
  • Ensure timely completion of tasks by project milestones
  •  

    Physical Requirements

    A certain amount of international travel is required for training purposes, collaboration, and/or management meetings with other departments in Denmark, Mexico, and India.

     

    Development of People

    Supervisory, ensure that reporting personnel have Individual Development Plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

     

    Qualifications

  • A Bachelors degree required. An advanced degree is preferred (M.S., Pharm.D., Ph.D., M.D.)
  • At least twelve years of experience is required, related to Scientific, Regulatory, Pharmaceutical and Medical areas, with at least five years of experience in the Patient Safety area preferred
  • Supervisory management experience of at least five years is required
  • Knowledge of international Pharmacovigilance legislation and guidelines         
  • Good knowledge of business processes, including IT systems (including databases and web solutions) required for the establishment of efficient handling of safety information
  • Knowledge of GMP and GCP requirements, including GXP documentation
  • Experience with working in international and diverse professional groups 
  • Excellent people leadership and interpersonal skills as well as professional authority
  • Good communication skills
  • Fluency in English, both written and spoken
  • Ability to perform timely and effective performance management
  • Demonstration of independence and initiative in decision-making that involves coordination with other internal and external stakeholders
  •  

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

     

    At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

     

    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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

    Refer code: 8006211. Biospace - The previous day - 2024-01-30 03:23

    Biospace

    Plainsboro, NJ
    Jobs feed

    Security Officer

    Decatur Public Schools

    Decatur, IL

    $32.2K - $40.8K a year

    Distribution Manager / Distribution / Full Time

    Catawba Valley Medical Center

    Hickory, NC

    $81.6K - $103K a year

    Bottling Line Operator

    Synergy Labs

    Hildebran, NC

    From $16.50 an hour

    Customer Service

    Marcal Paper Company

    Hickory, NC

    $19.50 an hour

    Deluxer/Final Inspector

    Century Furniture

    Hickory, NC

    $30.4K - $38.5K a year

    Freezer Warehouse Selector

    Mdi

    Hickory, NC

    $21.60 - $24.40 an hour

    Safety Technician

    Brown & Root

    Decatur, IL

    $50 - $55 an hour

    Warehouse Associate Freezer Area 1st Shift

    Ht Hackney

    Newton, NC

    Up to $20 an hour

    Dispatch Administrative Assistant

    Queen Transportation, Llc

    Hickory, NC

    $18 - $20 an hour

    Operations and Policy Analyst 3 - Youth Experiencing Homelessness Program

    Department Of Human Services

    Salem, OR

    $5,747 - $8,831 a month

    Share jobs with friends

    Related jobs

    Director - Patient Safety Hub Management

    Patient Safety Senior Associate

    Biospace

    Plainsboro, NJ

    7 days ago - seen

    Patient Safety Specialist

    Biospace

    Plainsboro, NJ

    7 days ago - seen

    Director, Patient Safety, TA Safety Physician (Virology)

    Gilead Sciences, Inc.

    Parsippany, NJ

    3 weeks ago - seen

    Director, Global Patient Safety - Immunology & Inflammation

    Biospace

    Basking Ridge, NJ

    3 weeks ago - seen

    PATIENT SAFETY COORDINATOR - PER DIEM

    Cooper University Health Care

    Camden, NJ

    4 weeks ago - seen

    Specialist - Patient Safety Training

    Biospace

    Plainsboro, NJ

    a month ago - seen

    Associate Manager - Patient Safety

    Biospace

    Plainsboro, NJ

    2 months ago - seen

    Patient Care Technician/Patient Safety Attendant

    Brih It C/O Compu Vision Consulting

    Up to $21 an hour

    Old Bridge, NJ

    3 months ago - seen

    Patient Safety & Risk Manager

    Englewood Health

    $79.7K - $101K a year

    Englewood, NJ

    3 months ago - seen

    Patient Safety Assistant

    Hunterdon Health

    $33.7K - $42.7K a year

    Flemington, NJ

    4 months ago - seen

    RN Patient Safety Manager

    Holy Name Medical Center

    Teaneck, NJ

    4 months ago - seen

    Patient Safety Attendant - PSA24-01591

    Evergreen Technologies, Llc.

    Newark, NJ

    4 months ago - seen

    Patient Safety Attendant - PSA24-01591

    Evergreen Technologies, Llc.

    Rahway, NJ

    4 months ago - seen

    Patient Safety Attendant - PSA24-01591

    Evergreen Technologies, Llc.

    Elizabeth, NJ

    4 months ago - seen

    Director - Patient Safety - Case Management

    Biospace

    Plainsboro, NJ

    4 months ago - seen

    Business Analyst - World Wide Patient Safety IT

    Bristol-Myers Squibb Company

    Berkeley Heights, NJ

    4 months ago - seen

    Virtual Safety Associate (River Edge, NJ), Nursing Assistant, Patient Care Tech

    Health Sitter Solutions

    River Edge, NJ

    5 months ago - seen

    Patient Safety Risk Manager

    International SOS

    Rio Grande, NJ

    5 months ago - seen