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1.0 - 10.0 years
0 Lacs
maharashtra
On-site
The Lead Medical Affairs - Clinical Trials - Dermatology (MD) will serve as the primary medical expert for assigned clinical trials within the dermatology therapeutic area, bridging the gap between clinical development, commercial teams, and external stakeholders. Your role will require a strong understanding of clinical research methodologies, regulatory requirements, and the ability to translate scientific evidence into actionable medical strategies. You will be based in Bandra, Mumbai, and your responsibilities will include providing medical and scientific expertise for the design, execution, and interpretation of clinical trials (Phases I-IV) in Dermatology & Venereology in India. You will ensure medical oversight of ongoing clinical studies, including safety monitoring and data review, adhering to GCP and Indian regulatory guidelines (CDSCO). Collaboration with global and local R&D/Clinical Development teams on clinical strategy and protocol development will be essential. Engaging with Key Opinion Leaders (KOLs) and healthcare professionals, disseminating scientific information, and gathering market insights will also be part of your responsibilities. Additionally, you will contribute to publication strategies and deliver scientific presentations of clinical trial data while ensuring that all medical affairs activities comply with industry regulations and company policies in India. To qualify for this position, you should hold an MBBS + MD with a specialization in Dermatology or DDVL. A total of 8-10 years of experience with a minimum of 1 year in clinical trials or 10+ years in medical affairs in the pharmaceutical industry is required. In-depth knowledge of clinical trial methodology, study design, and statistical principles, along with a thorough understanding of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA, Indian regulations), will be essential. Strong scientific and medical acumen in Dermatology, including disease pathology, current treatment landscapes, and emerging therapies, is also necessary. If you meet the qualifications and are interested in this opportunity, please share your resume at "monalim@wockhardt.com". Regards, Monali M Corporate HR,
Posted 1 week ago
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