Lead - Clinical Research, (RWE) Medical Affairs

Reporting to General Manager– Medical Affairs, India

Team: 4 direct reports

Education: MD Pharmacology

Department: Medical Affairs

Location: Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Role and Responsibilities

Common Process Management

• Create, adapt and update SOPs & Work instructions for in-house initiated and CRO driven non-regulatory interventional clinical studies, observational studies, cooperative group studies, registries, PRO, EMR studies & IIS

• Ensure adherence to GCP, trial protocols, applicable regulations and administrative requirements for all studies driven by India Medical Affairs

• Develop trackers and monitoring system to track execution of all studies in alignment with plan

• Evaluate IIS concepts received from externals stakeholders in alignment with the IIS SOP and facilitate review with the core group in alignment with the IIS SOP

• Work closely with TA Medical Lead/Advisor for study related activities

• Act as the point of contact for all external and internal agencies