Job Title:

Senior Manager - Medical Science

Business Unit:

MACR

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 cooperative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

YOUR TASKS AND RESPONSIBILITIES:

Lead the clinical trial medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subject’s expert committee (SEC) regulatory meeting.
Planning publications activities for clinical journal manuscripts, clinical journal abstracts, and study article.



Identify additional clinical data analysis in collaboration with statistics team and subsequently submission and present the data in scientific forums
Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis.
Review of patient eligibility and approval of patients through Interactive Response Technology (IRT) system
Work with data management team to review data management plan, coding plan, SAE reconciliation, CRF completion guidelines, edit check specifications. Also to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs).
Coordinate with biostatistician to engage early with the study team to decide sample size, statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents
Prepare risk assessment plan based on

📌 Sr. Manager (Mumbai)
🏢 Sun Pharmaceutical Industries
📍 Mumbai