Title:  Medical Monitor

Job Location: Bangalore

Department: Clinical Development – Medical & Regulatory Affairs

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Description:

Role: Associate Research Physician/Associate Manager

Key Responsibilities: 

• Associate Research Physician in clinical trial related projects covers various therapeutic areas, medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation and in accordance with applicable regulatory and SOP requirements.
• Support in the preparation and review of protocol related appendices like Investigator’s Brochure, Informed Consent Document, Investigator’s Undertaking, and any other documents related to protocol and CSR.
• Review of the MedDRA and WHO Drug Insight coding as and when required for the projects.
• Support the Senior Research Physician in generating SAE narratives and performing quality review and analysis of similar events.
• Communication of the SAE to all stakeholders as per the format and timelines indicated in the guidelines and internal SOP and keep a track of the same when required for clinical trials.
• Take a lead role in drafting the Integrated Summary of Safety and Efficacy for all clinical trial projects where in he/she is designated the responsibility.
• Review of protocol and protocol synopsis for BA/BE and phase studies in collaboration with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitor.
• Preparation of Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS), if applicable.
• Preparation of SFQs (Site Feasibility Questionnaires) and summary for patient-based studies.
• Training the required study team members and addressing protocol related queries in a   timely manner.
• Provide input regarding deliverables with accuracy timelines and processes and support completion of quality regulatory documents.
• Managing documents with multiple review cycles and deadlines.

Educational Qualification: 

MBBS MD Pharmacology.

Experience: 

2-5 years

Behavioral Skills:

• Should have good communication skill and should be a good team player.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be a focused employee.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.