Medical Affairs Project Manager
21 hours ago
Prestige Biopharma Limited is seeking a highly skilled Medical Affairs Project Manager to join our team. As a key member of our Medical Affairs department, you will play a critical role in supporting the development and lifecycle management of our products.
Key Responsibilities- Document Development and Review
Develop, review, and edit documents for clinical studies and regulatory submissions, including protocols, Investigator's brochure, study reports, dossiers, and responses to regulatory authorities.
- Study Design and Analysis
Facilitate the design and analysis of clinical studies, ensuring that they are conducted in accordance with Good Clinical Practice (GCP) and regulatory requirements.
- Scientific Communication
Prepare scientific abstracts, presentations, and publications to showcase our research and development pipeline, highlighting the benefits and value of our products.
- Literature Search and Analysis
Conduct comprehensive literature searches to support product development and decision-making, staying up-to-date with the latest scientific developments and regulatory requirements.
- Communication and Collaboration
Develop and maintain effective relationships with cross-functional teams, including research and development, regulatory affairs, and commercial operations, to ensure seamless communication and collaboration.
Requirements- Education and Experience
A Bachelor's degree (or higher) in life sciences, clinical sciences, or a related field, with a minimum of 3 years of experience in clinical research, medical affairs, or medical writing.
- Skills and Competencies
Strong knowledge of ICH guidelines, clinical research methodologies, and statistical principles, with excellent communication and interpersonal skills, and the ability to manage multiple stakeholders.
- Technical Skills
Proficient in Word, Excel, PowerPoint, and other standard software tools, with experience using style guides and regulatory submission requirements.
What We OfferPrestige Biopharma Limited offers a competitive salary and benefits package, as well as opportunities for professional growth and development in a dynamic and innovative environment.
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