Bengaluru, Karnataka, India
Experienced professional with over a decade of experience in clinical research, medical affairs, and cultural partnership roles within the pharmaceutical industry, working as a writer, project coordinator, and project manager focused on clinical disclosure and medical affairs.
• Actively involved in the cultural onboarding of new managers and employees at an organizational level at GBS. • Partnering with HR BPs and leadership to align D&I initiatives with company values and goals. • Collaborating with Employee Resource Groups (ERGs) to support their initiatives and ensure their influence in shaping culture. • Driving communication efforts to inform employees about cultural and D&I initiatives, updates, and involvement opportunities. • Acting as a champion for Novo Nordisk's culture and D&I programs, promoting the value of diverse perspectives and developing a network of NNWay Champions locally. • Curating and presenting workshops/sessions to enhance team and departmental culture. o Implicit bias and Microaggressions o Feedback o Understanding stress and ways to manage it. o Effective collaboration • Be available as the GBS Go-To person for questions related to NNWay and Novo Nordisk Culture. • Trainer for Global Feedback Program/ workshops. • Program manager for all-level GBS Leaders Summit.
• Providing specialist scientific strategic and operational input into core medical affairs activities to ensure consistency across the Rare Disease product portfolio and identify improvement areas. • Leading KOL management and strategy, driving IEP development, and tracking adherence across Rare Disease Medical Affairs, including maintaining an updated expert directory. • Driving KOL mapping projects based on therapy needs to identify and engage relevant KOLs. • Anticipating stakeholders’ and/or opinion leaders’ needs and assesses them in order to offer tailor-made solutions which fit Novo Nordisk’s strategy. • Applying best practices and considering broad cross-portfolio/functional requirements and implications for new projects. • Sharing and communicating results and learnings with stakeholders, from opinion leaders to senior management and affiliates. • Ensuring the use of the best communication channels, considering stakeholders’ characteristics. • Building strong and effective relationships with relevant affiliates and providing clear, motivating communication.
• Manage end-to-end project management for medical education meetings and events related to Diabetes and Obesity by the Global Medical Affairs team. • Identify and liaise with vendors efficiently to meet project needs. • Handle stakeholder management to maintain engagement and strengthen relationships. • Oversee detailed budget responsibilities in alignment with team and organizational processes (e.g., PA/PO, RE/AB reporting). • Identify risks and propose mitigation actions during project execution. • Ensure cross-functional alignment and secure project endorsement. • Maintain project visibility and provide updates in relevant communication forums like GMA quarterly meetings. • Mentor new hires in project management and participate in their onboarding process. • Lead continuous improvement initiatives by developing project management templates. • Share learnings with the team and coordinate synergies across concurrent projects. • Take charge as congresses/events lead from a project management perspective, including advisory boards and major events like ESC, IFSO, IDF, ISPAD, and NN Standalone events involving HCPs worldwide. Congresses/events lead from a project management perspective: • Ad board for IDegAsp launch in China • Congress experience: ESC, IFSO, IDF, ISPAD (observer and support) • NN Standalone events: GDS (Global Diabetes Summit)
Planning and Delivery: • Planning, tracking and timely delivery and disclosure of clinical trial disclosure documents per the company policy, covering regulatory requirements of documents according to the company policy and regulatory requirements. • Coordinating the process of delivery of protocol & result summaries and other clinical trial disclosure obligations according to a plan and process established by the central disclosure team. • Ensuring alignment of documents content with requirements. • Maintaining full audit trails of each document developed. Project Management related activities: • Actively drives the development of clinical trial disclosure documents delivery plans and the timely delivery of those documents as per the regulatory requirements (NIH, EudraCT, EMA PASS, German registry, etc). • Optimal usage of tools for planning, tracking and delivery and for the posting of the documents on the required registries. Process excellence & Mentoring: • Training and mentoring of newcomers on the preparation and disclosure of protocol and result summaries, as needed. • Involved in the development and improvement of process documents updates (e.g. SOPs, Guidelines, Templates), thereby exploring & enhancing my project management skills. • Supporting the development and implementation of new processes required to fulfill new requirements & ensuring proper documentation of these new processes. • Lead/execute problem solving sessions for identified topics. • Played the role of a change agent whilst identifying areas of improvement and fostered a positive attitude toward change.
• Writing & reviewing protocol and result summaries as per the Regulatory requirements, to ensure timely disclosure and quality in alignment with disclosure requirements. • Coordinating the process of delivery of protocol & result summaries and other clinical trial disclosure obligations according to a plan and process established by the central disclosure team. • Redaction of personally identifiable information & patent sensitive information prior to submission of documents to regulatory authorities • Submitting the documents within the timelines as per the SOPs and regulatory requirements (NIH, EUDRACT, EMA PASS, German registry, etc). • Reviewing the data between the Result summary of a study and its corresponding report, to ensure minimum or no discrepancies. • Knowledge of writing Protocols, Clinical Study Report (CSR), Informed Consent Form (ICF). • Training and mentoring of newcomers on the preparation and disclosure of protocol and result summaries, as needed. • Well versed with tools like Datavision and Veritas Clinical Trial Register.
• Working towards solving the players queries regarding online games • Helping the licensees resolve players problems and queries via emails and online chat. • Working with specialists to resolve access problems that may be encountered by admin users • Analyze, troubleshoot and resolve problems that are received via email, through the Online Support of various casinos • Working as a team in resolving all the queries of the clients • Using a polite and easy to understand language while replying to all emails • Providing a quick response to the licensees with queries while chatting online