Site Manager, Expanded Access Programs

View full description

Requirements:

• Have a (bio)medical degree or background
• +2 years of relevant work experience in Healthcare or Life Sciences.
• Hold excellent verbal and written communication skills in English and Hindi.
• Proficient in Microsoft Office tools, with a focus on Excel
• Are self-motivated, adaptable, and thrive in a fast-paced environment where change is continuous

Responsibilities:

• Serving as the first point of contact for physicians and their supportive staff throughout the EAP process and coordinating communication with external stakeholders including physicians, pharmacists, clinical trial coordinators, and sponsors in India.
• Facilitating document exchange and processing HCP patient requests for medicinal products.
• Managing customer management tools including processing patient data into the Electronic Data Capture (EDC) system(s) as needed and generating client reports where required.
• Reviewing documents/data collection, identifying discrepancies, and collaborating with sites to fulfill regulatory requirements.
• Collaborating closely with cross-functional teams within our Expanded Access Operations unit (e.g., Regulatory Affairs, Quality, Program Management, Supply Chain) to ensure smooth operations.
• Drafting and updating program documentation leveraging existing departmental templates and/or designing new templates.
• Supporting Program Managers (PMs) with oversight and maintenance of electronic Master Files and improving program processes.
• Communicating with clients and maintaining a high-level of client satisfaction.