- Location
- Telangana (Sandoz), India
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Senior
- Experience
- 8+ years
- Closing date
- Today
- Source
- Workday
Description
Job Description Summary
Responsible for delivery of Medical Legal Regulatory (MLR) asset support and related system super user activities within the Medical Excellence Operations organization based out of GCC India. The role ensures high-quality, compliant, and efficient execution of MLR workflows, drives process consistency and documentation discipline, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery and continuous improvement across MLR asset support services.Job Description
Responsible for delivery of Medical Legal Regulatory (MLR) asset support and related system super user activities within the Medical Excellence Operations organization based out of GCC India. The role ensures high-quality, compliant, and efficient execution of MLR workflows, drives process consistency and documentation discipline, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery and continuous improvement across MLR asset support services.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Own end-to-end delivery of MLR asset support services, including workflow coordination, submission support, metadata / documentation discipline, and process consistency.
Manage higher-complexity MLR submissions and asset-related workflows, including submission preparation, quality checks, upload, annotation, tagging, linking, and metadata updates, as applicable.
Establish and maintain subject matter expertise for MLR systems and associated workflows, including system end user support.
Manage user onboarding, training support, process communication, and follow-up trainings related to MLR systems and processes, as applicable.
Coordinate with Global Medical Affairs, business owners, reviewers, agencies, Technology / Digital, and other relevant stakeholders to ensure timely and accurate execution of MLR workflows.
Manage query handling, issue resolution, and stakeholder follow-up across MLR asset support activities within scope. Maintain process discipline, documentation quality, and readiness for process / system changes, enhancements, and related operational updates.
Deliver metrics, reporting inputs, and service indicators to support oversight, performance visibility, and continuous improvement. Supports system testing in case of system changes. Support the transition and stabilization of services into GCC and contribute to process standardization, documentation, and operational maturity.
What you’ll bring to the role:
Essential Requirements:
MLR asset support services and related operational processes are delivered effectively and in line with defined quality and service expectations.
Higher-complexity submission support, metadata updates, asset documentation, and system-based activities are delivered accurately and within agreed timelines. System end user support, training, user enablement/management, and stakeholder coordination are delivered consistently and effectively.
Documentation discipline, process consistency, and issue resolution are maintained effectively across the MLR service model.
Act as MLR system super user and support MLR system testing (as needed).
Identified risks / gaps are addressed in a timely manner, with appropriate remediation and continuous improvement actions.
Advanced degree or equivalent qualification in life science, healthcare, pharmacy, medicine, business operations, or related field preferred with 8–12+ years experience in the pharmaceutical / healthcare industry, ideally with experience in Medical Affairs operations, MLR operations, content / asset workflows, submission support, and related support models.
Subject matter expertise in MLR workflows, asset management, metadata handling, submission coordination, system support, and documentation requirements in Medical Affairs support environments.
You’ll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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)Skills
Clinical TrialsPatient Care
