Medical Affairs Job at SUN Pharma
Are you ready to take your medical career to the next level? The Manager – Medical Science at Sun Pharma will play a crucial role in advancing clinical research and development. This Medical Affairs Job in Mumbai involves overseeing medical monitoring activities, preparing clinical documents, and collaborating with clinicians and key opinion leaders. With a strong understanding of clinical trials, the successful candidate will provide medical expertise throughout the study process, ensuring that projects are executed to the highest standards.
About Sun Pharma Laboratories Ltd:
Sun Pharma Laboratories Ltd is a leading pharmaceutical company operating in the healthcare sector. Known for its commitment to innovation and quality, the company focuses on developing and manufacturing a wide range of pharmaceutical products. Headquartered in Mumbai, India, Sun Pharma is dedicated to improving patient outcomes through advanced medical solutions.
Job Details:
- Title: Manager – Medical Science
- Location: Mumbai
- Company: Sun Pharma Laboratories Ltd
Job Description:
The Manager – Medical Science will be responsible for overseeing medical monitoring activities, preparing clinical documents, and collaborating with clinicians and key opinion leaders. This role requires a strong understanding of clinical trials and the ability to provide medical expertise throughout the study process.
Key Responsibilities:
- Medical monitoring activity including eligibility assessment based on inclusion and exclusion criteria, detailed medical history, review of study endpoint data, and safety investigations.
- Preparation of synopsis, protocol, Clinical Study Report (CSR), and presentation of proposals in subject expert committee (SEC) regulatory meetings.
- Collaboration with clinicians and KOLs to gather feedback on clinical trial design, comparators, and study endpoints.
- Review of patient eligibility and approval of patients through the Interactive Response Technology (IRT) system in the Medical Affairs Job.
- Collaboration with the data management team to ensure timely data extraction and participation in data cleaning activities.
- Training the study team on protocol and its applied aspects, emphasizing the relevance of each activity concerning study endpoints in this Job in Mumbai.
- Interaction with investigators to resolve queries related to the protocol from the sites and Ethics Committee.
- Review of adverse event (AE) and serious adverse event (SAE) forms and providing timely review comments.
- Medical writing of scientific documents.
- Planning publication activities for clinical journal manuscripts and abstracts, and identifying additional clinical data analysis in collaboration with the statistics team.
Eligibility Criteria for the Medical Affairs Job:
- Educational Qualification: MBBS + MD (Pharmacology)
- Experience: 1-2 years of previous work experience.
Required Skills for the Medical Affairs Job:
- MD (Pharmacology) or other relevant medical qualification with 1-2 years of relevant experience or fresher.
- Experience in the clinical science domain, working in various capacities as a medical monitor for clinical trials or medical expert for clinical development plans across therapies is desirable.
