Job Description Summary
The Medical Operations Lead supports the TA Content Development Team on various operational aspects of assigned projects/activities. The role also provides project support to the Scientific Writer across the delivery lifecycle with agreed specific responsibilities related to Fuse/MLR review and approval which will help the writer to focus on the scientific content.
Job Description
Location – Hyderabad #LI Hybrid
Major Responsibilities:
- Execute services and meet planned deliverables in line with defined roles and responsibilities agreed with business colleagues.
- Support set-up and maintenance of information in Datavision and other systems as applicable: Update data, timelines, milestones, author agreements, debarment checks, Ethics Committee (EC)/Health Authority (HA) authorizations, etc. on an ongoing basis.
- Support TA Scientific Lead with budget management, ensuring accurate planning, tracking and reporting of budget as applicable. Perform Good receipt booking in line with Vendor financial report and project status, as required.
- Support set-up and maintenance of Veeva Vault (or other content repository): Ensuring that all key documents are present and approved as appropriate. Follow up with Medical Communications Lead at agreed frequency for maintenance.
- Support in External Service Provider coordination including contract, procurement and budget management
- Responsible for project management support to the Scientific Writer ensuring the end-to-end effective project delivery and approval through medical legal regulatory review across:
- Initiate and create / amend a submission package (as required)
Minimum Requirements:
Education
Relevant educational background in life sciences/Healthcare (Ideally a bachelor's degree or above in life sciences) or equivalent combination of education, training and experience.
Experience Required
3-4 years of operational experience in a pharmaceutical company: 1 – 2 years' experience with medical legal review or relevant industry experience a plus
Skills/Qualifications
Experience in finance: forecast, actuals, cost reconciliation, a plus
Strong technical and organizational skills (Excel, PowerPoint)
Detail oriented.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Skills Desired
Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)
