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Job Details
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
Developing Quality and US Operations (USO) strategic objectives and strong business understanding of the value chain and customer focus.
This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control. Additionally, this role provides SME-level input from the affiliate perspective when required. This role also provides direct support for continuous improvement initiatives, locally or globally driven, for the covered processes.
Relationships
Reports to the Director, Quality Assurance. Interfaces with multiple NNA/S Quality departments and Quality departments in global affiliate offices. Drives and maintains a positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g. interactions with NNI vendors during periodic auditing functions and routine networking through membership in industry association(s).
This job is an individual contributor and does not have dotted line relationships or responsibilities for direct management of contingent workers.
Essential Functions
Deviation Management Acts in role of Quality Assurance for NN Deviation process within the PV domain, including review and disposition of submitted deviations in the Vault Quality system. Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Deviation process requirements. Execute regular surveillance, follow-up, and reporting program to ensure local process compliance. Acts in role as process SME for the Deviation process at USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.
Change Control Supports the affiliate (i.e. Regional) Center of Excellence (COE) for the Change Control process with specific focus in the PV domain. Acts in the role of Quality Assurance for NN Change Control process, including review and disposition of submitted change requests in the Vault Quality system. Execute regular surveillance, follow-up and reporting to ensure local process compliance. Acts in role of process SME for the Change Control process at USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations. Content Control Acts in role of Quality Assurance for NN Content Control process, including review and disposition of submitted standard operating procedures (SOPs) or other similar documents within the QualityDocs system. Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance. Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Content Control process requirements within the PV domain. Acts in role as process SME for the Content Control process across USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations. Quality Assurance Provides secondary support to all USO Quality Management processes, including but not limited to Product Disposition and/or Audits and Inspections, as necessary.
Physical Requirements
0-10% overnight travel required.
Qualifications
Education Level:Bachelor's degree required; relevant experience may substitute for degree, when appropriate; advanced degree preferred
Experience Level:Requires a minimum of 9 years of progressively responsible related experience, with at least 4 years working within or directly collaborating across the PV domain; pharma experience preferred
Specific or technical job skills:Excellent interpersonal skills and ability to interact with staff across all levels. Demonstrated ability to work independently without appreciable direction. Capability to identify, evaluate, and resolve complex issues that require reviewing multiple factors to determine proper resolution, with management support as needed. Demonstrated problem solving skills, creativity, and initiative
The base compensation range for this position is $116,810-$216,100. 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.
We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
Company
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com .
Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.
CONNECT
Company info Website https://www.novonordisk-us.com/ Phone 617-612-6200 Location 75 Hayden Avenue Lexington MA 02421 United States
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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
Developing Quality and US Operations (USO) strategic objectives and strong business understanding of the value chain and customer focus.
This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control. Additionally, this role provides SME-level input from the affiliate perspective when required. This role also provides direct support for continuous improvement initiatives, locally or globally driven, for the covered processes.
Relationships
Reports to the Director, Quality Assurance. Interfaces with multiple NNA/S Quality departments and Quality departments in global affiliate offices. Drives and maintains a positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g. interactions with NNI vendors during periodic auditing functions and routine networking through membership in industry association(s).
This job is an individual contributor and does not have dotted line relationships or responsibilities for direct management of contingent workers.
Essential Functions
Deviation Management Acts in role of Quality Assurance for NN Deviation process within the PV domain, including review and disposition of submitted deviations in the Vault Quality system. Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Deviation process requirements. Execute regular surveillance, follow-up, and reporting program to ensure local process compliance. Acts in role as process SME for the Deviation process at USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.
Change Control Supports the affiliate (i.e. Regional) Center of Excellence (COE) for the Change Control process with specific focus in the PV domain. Acts in the role of Quality Assurance for NN Change Control process, including review and disposition of submitted change requests in the Vault Quality system. Execute regular surveillance, follow-up and reporting to ensure local process compliance. Acts in role of process SME for the Change Control process at USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations. Content Control Acts in role of Quality Assurance for NN Content Control process, including review and disposition of submitted standard operating procedures (SOPs) or other similar documents within the QualityDocs system. Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance. Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Content Control process requirements within the PV domain. Acts in role as process SME for the Content Control process across USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations. Quality Assurance Provides secondary support to all USO Quality Management processes, including but not limited to Product Disposition and/or Audits and Inspections, as necessary.
Physical Requirements
0-10% overnight travel required.
Qualifications
Education Level:Bachelor's degree required; relevant experience may substitute for degree, when appropriate; advanced degree preferred
Experience Level:Requires a minimum of 9 years of progressively responsible related experience, with at least 4 years working within or directly collaborating across the PV domain; pharma experience preferred
Specific or technical job skills:Excellent interpersonal skills and ability to interact with staff across all levels. Demonstrated ability to work independently without appreciable direction. Capability to identify, evaluate, and resolve complex issues that require reviewing multiple factors to determine proper resolution, with management support as needed. Demonstrated problem solving skills, creativity, and initiative
The base compensation range for this position is $116,810-$216,100. 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.
We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
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.
Company
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com .
Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.
CONNECT
Company info Website https://www.novonordisk-us.com/ Phone 617-612-6200 Location 75 Hayden Avenue Lexington MA 02421 United States
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