Clinical Strategy Expert Vacancy at Dr. Reddy’s | Apply Now
Are you an experienced clinical strategy expert passionate about shaping the future of generic pharmaceuticals? Dr. Reddy seeks a dynamic professional to conceptualize and implement innovative strategies for complex formulations like liposomal and depot preparations. Join a team that values excellence, regulatory expertise, and market-driven innovation.
Job Posting: Clinical Strategy Expert
Job Description
Job Summary: We seek an experienced Strategy Expert to conceptualize plans for complex generic products, including liposomal formulations or depot preparations. Your responsibilities will involve developing integrated strategies that are both cost-effective and timely, ensuring alignment with regulatory requirements and market demands.
Roles & Responsibilities
- You will be assisting in conceptualizing plans for complex generic products, such as liposomal formulations or depot preparations. This entails developing integrated strategies that are both cost-effective and timely.
- Your role involves conducting due diligence on in-licensing dossiers for developed markets and performing medical evaluations of business deals. This ensures that only the best products are selected for in-licensing and business deals.
- You will be responsible for supporting portfolio teams by providing medical evaluations and clinical strategies at pre-Apex and Apex meetings, ensuring that future product selections are grounded in sound medical and clinical reasoning.
- You will be responsible for developing plans to facilitate clinical-regulatory discussions with regulatory agencies, aiming to secure clinical waivers and positive opinions on innovative clinical approaches through scientific advice meetings and controlled correspondence.
- You will lead a team in preparing clinical dossiers for submission to regulatory agencies in developed markets, facilitating quality submissions within specified timelines.
- You will oversee statistical resources for developing plans and conducting analyses in clinical studies, ensuring robust statistical methodology and final study outputs.
Qualifications
- Education Qualification: MD/DM- Pharmacology
- Minimum Experience Required: 3-5 years of working experience in the clinical operations department of a Clinical Research Organisation/Sponsor
Skills & Attributes
Technical Skills:
- Understanding of the Indian Pharmaceutical Industry
- Experience in clinical projects management, SO & process improvement
- Experience in managing clinical budgets, Statutory & Regulatory Guidelines like Good Clinical Practice (GCP), New Drugs and Clinical Trials Rules, 2019 (NDCT), USFDA, EU
Behavioral Skills:
- Excellent communication and interpersonal skills
- Efficient Leader and a good collaborator
- Good at building and leveraging relationships
- Strong analytical and problem-solving abilities
- Strong decision-making skills
Additional Information
About the Department: Global Generics India
In the last three decades, Dr. Reddy’s Global Generics India has grown as a trusted name in the healthcare industry and ranks as one of the top 10 Pharma Companies in the Indian Pharma Market. Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position in the last four years. We are a fast-growing organization with double-digit growth and significant market share in domestic markets. Currently, we rank among the top in various therapy areas. Our focus is on leveraging digital capabilities, collaborations, innovations, and inorganic opportunities to become one of the top pharmaceutical companies in the Indian Pharma Market.
Benefits Offered
At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things, joining & relocation support, family support, learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work daily, and they’ll say because Good Health Can’t Wait. This is our credo and the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives. We foster a culture of empathy and dynamism. People are at the core of our journey. We believe that when a common purpose and value system binds together people with diverse skills, they can make magic.
Keywords: Clinical Strategy Expert Job, Pharmaceutical Clinical Strategy, Liposomal Formulation Specialist, Depot Preparations Expert, Regulatory Affairs in Pharma, Clinical Research Job in Pharma
