Job title: Medical Reviewer

Company: Novo Nordisk

Job description: Can you drive the global strategy for culture, engagement, and performance Management at Novo Nordisk? Do you have the interpersonal Skills to navigate in a complex stakeholder landscape and are you able to motivate, set direction and deliver results? At Novo Nordisk, we are our people. And together we can make an impact.

Apply now and join the Novo Nordisk P&O organisation as our new Medical Reviewer.

The Position:

Medical Reviewer Position is responsible for Medical Review of all trial subjects of all assigned clinical trials to ensure high quality consistent medical data. Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations and Standard Operating Procedure (SOPs). Medical Reviewer ensures high quality medical data through medical review of clinical trial data. Develop good therapeutic knowledge and general understanding of diseases and treatments as well as the latest medical developments. Develop good understanding of relevant protocol and trial specific manuals/plans to ensure quality deliverables.

Stay updated on training as required for the role as well as individual competency development. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s) and Medical Specialists during trial conduct. Report status of medical review to project as appropriate, following the project communication plan and blinding plan. Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manner.

• Responsible for contribution to or participation in trial planning activities related to medical review.
• Responsible for clarifying and if possible resolving issues of medical concern. and/or inconsistencies in clinical trial data with staff at investigational sites.
• Responsible for presenting findings of Medical Review to relevant Medical Specialist to enable decision making.
• Responsible for documenting medical review in the sponsor TMF.

Qualifications:

• Minimum as Graduate in Medicine or other relevant (MBBS & MD, MBBS & other relevant Medical courses with Regular/Real Time experienced candidates are only Preferred).
• 3+ years of experience as Medical Reviewer is preferred.
• Good knowledge of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ), GCP (Good clinical Practice).
• Demonstrated computer skills (MS Office, MS Project, PowerPoint).
• Excellent understanding of medical terminology and clinical trial activities.
• Excellent written and spoken English.

About the Department

Clinical Data Science, Global Business Services (CDS GBS) was started in September 2007 and within a short span of eight years since its inception, has transitioned from a small start-up to one of the largest units in GBS and a key contributor to Novo Nordisk clinical development portfolio. As the organisation is growing along with the Research & Development portfolio, we are looking for several new medical Reviewing colleagues. In Clinical Data Science, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. The CMU support is established in GBS to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is responsible for performance of centralised medical review of patient data that includes medical monitoring and lab surveillance; and generation of visualisations and reports identifying outliers and trends from various data sources.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact

• Please submit your application online at your earliest convenience, including a motivational letter and CV in English (Click on Apply Now and follow the instructions).

Deadline

• Applications will be screened on an ongoing basis & Interviews will be conducted continuously, so you are encouraged to apply as soon as possible on or before 26th July,2022.

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.

Expected salary:

Location: Bangalore, Karnataka

Job date: Thu, 14 Jul 2022 22:33:30 GMT

Apply for the job now!