Manager - Medical Science

Sun Pharmaceutical Industries; Mumbai; On-site; INR 1,400,000 - 2,300,000; Full time

Job summary

Sun Pharma in Mumbai is seeking a Manager - Medical Science to lead medical monitoring for clinical studies, assess patient eligibility, and coordinate with investigators across therapeutic areas.

You will prepare protocols, CSR, and present proposals to the SEC, while collaborating with clinicians and KOLs to refine trial design and endpoints. This role also involves data review, IRT use, team training, and contributing to publications.

Qualifications

• MBBS and MD (Pharmacology) or equivalent.
• 1-2 years of clinical trial/medical monitoring experience.
• Experience in clinical science domain and regulatory meetings is desirable.

Responsibilities

• Medical monitoring and eligibility assessment based on inclusion/exclusion criteria and medical history.
• Prepare synopsis, protocol, CSR and present in SEC regulatory meeting.
• Collaborate with clinicians and KOL on trial design, endpoints and synopsis.
• Review patient eligibility and approval via IRT system.
• Coordinate data cleaning and timely database lock and release of TLFs.
• Train study team on protocol and relevance to endpoints.
• Interact with investigators to resolve protocol queries with sites and Ethics Committee.
• Review AE/SAE forms and provide timely comments.
• Medical writing of scientific documents.
• Plan publications for clinical journal manuscripts and abstracts.

Skills

Medical monitoring

Clinical trial design

Data review

Team collaboration

Education

MBBS

MD (Pharmacology)

Tools

IRT system

Job description

Job Title:

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 collaborative spirit, knowing that we 'Thrive together' and support each other's journeys.

YOUR TASKS AND RESPONSIBILITIES:

• Medical monitoring activity which includes eligibility assessment based on inclusion, exclusion criteria and detailed medical history, review of study endpoint data review and safety investigations.
• Preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subject's expert committee (SEC) regulatory meeting.
• 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 timely data extract and participate in data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs).
• Training the study team on protocol and applied aspect of the protocol to clarify the relevance and criticality of each activity considering the study endpoints.
• Interact with investigator to resolve the queries related with protocol from the sites and Ethics Committee.
• Review of AE and SAEs forms and provide review comments in timely manner
• Medical writing of scientific documents
• 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

Job Requirements

Educational Qualification

MBBS +MD (Pharmacology)

Experience

1 -2 years previous work experience.

Skills required include:

• MD (Pharmacology) or other relevant medical qualification with 1-2 years of relevant experience or fresher.
• Experience in working in clinical science domain working in different capacities as medical monitor for clinical trial/ medical expert for clinical development plan for products across therapies is desirable.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).