Medical Affairs Project Manager

21 hours ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time
About the Role

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 Offer

Prestige 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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