Compliance Analyst

3-6 years

Not Disclosed

Baltimore

15 June 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Compliance Analyst

Department: Global Legal - Global Business Services (GL-GBS)

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with compliance objectives as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

About the Department

Global Legal - Global Business Services (GL-GBS) at Bangalore was established in 2011 and supports the Global legal organization across International Operations, North America Operations and Headquarters. The unit is anchored under Global Legal Operations and responsible for delivering efficient offshoring legal services in high quality. Examples include end-to-end contract management, trademark portfolio management, promotional materials review, export controls screenings, system/process management, data management, and digitalization.

Job Level: 5

The Position

As a Compliance Analyst, you will be actively involved in supporting Plan Study and Participant Engagement Activities along with facilitating qualitative field work and cross-functional stakeholder engagement which would also involve below mentioned responsibilities:

Managing study documentation - create a record of the study in the DD&IT overview of User Research Studies and corresponding folder structure for storage of study-related data and documentation on SharePoint and also plan how research participants are to be engaged, either directly or via a third-party supplier.

Pre-notify LRR (Local Reporting Responsible) - involve the Local Reporting Responsible (LRR) in the participants’ home country to ensure that the engagement is permitted under local laws and also determine Pharmacovigilance (PV) requirements such as likelihood of receiving Adverse Event or other Safety Information and classify the activity and register the study in HALO PV.

Shortlist suppliers, review the proposal with relevant stakeholders and determine if the supplier qualifies as a Third-Party Representative (TPR). If so, a TPR assessment must be conducted according to the process defined in the TPR playbook.

Conduct Pharmacovigilance assessment and make sure that it is reflected in our agreements and also ensure that the contract includes the relevant information according to the scope of the study and that all appendices are documented and signed in Coupa.

Contribute to group of activities in which Novo Nordisk, or a third party acting on our behalf, interacts with research participants (e.g. patients, Health Care Professionals (HCPs), caregivers) to gather information related to their experience, adoption or use of non-medical Health Software in Novo Nordisk therapy areas.

Qualifications

Bachelor’s Degree.
3-6 years of proven work experience in Compliance or similar role.
Strong interpersonal skills to handle complex stakeholders’ relationships.
Creative in trouble shooting when finding the legal and compliance pathways to enable us to do research. Critical thinking skills and solution oriented to optimise intelligence & reporting.
Creative in framing and tweaking guideline and processes.
Experienced in conducting research and writing additions to our compliance guideline to make new modes of research possible.
Very well organized with strong team spirit.
Able to work in a matrix organisation with multiple stakeholders.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

21st June, 2024

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.

Job Title: Compliance Analyst

Department: Global Legal - Global Business Services (GL-GBS)

About the Department

Job Level: 5

The Position

Managing study documentation - create a record of the study in the DD&IT overview of User Research Studies and corresponding folder structure for storage of study-related data and documentation on SharePoint and also plan how research participants are to be engaged, either directly or via a third-party supplier.

Pre-notify LRR (Local Reporting Responsible) - involve the Local Reporting Responsible (LRR) in the participants’ home country to ensure that the engagement is permitted under local laws and also determine Pharmacovigilance (PV) requirements such as likelihood of receiving Adverse Event or other Safety Information and classify the activity and register the study in HALO PV.

Shortlist suppliers, review the proposal with relevant stakeholders and determine if the supplier qualifies as a Third-Party Representative (TPR). If so, a TPR assessment must be conducted according to the process defined in the TPR playbook.

Conduct Pharmacovigilance assessment and make sure that it is reflected in our agreements and also ensure that the contract includes the relevant information according to the scope of the study and that all appendices are documented and signed in Coupa.

Contribute to group of activities in which Novo Nordisk, or a third party acting on our behalf, interacts with research participants (e.g. patients, Health Care Professionals (HCPs), caregivers) to gather information related to their experience, adoption or use of non-medical Health Software in Novo Nordisk therapy areas.

Qualifications

Bachelor’s Degree.
3-6 years of proven work experience in Compliance or similar role.
Strong interpersonal skills to handle complex stakeholders’ relationships.
Creative in trouble shooting when finding the legal and compliance pathways to enable us to do research. Critical thinking skills and solution oriented to optimise intelligence & reporting.
Creative in framing and tweaking guideline and processes.
Experienced in conducting research and writing additions to our compliance guideline to make new modes of research possible.
Very well organized with strong team spirit.
Able to work in a matrix organisation with multiple stakeholders.

Working at Novo Nordisk

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

21st June, 2024

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

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