Job Description

• Writes, edits, and reviews Essential Documents, including protocols, clinical study reports (CSRs), CSR safety narratives, informed consent forms, patient information, regulatory submission documents (e.g., sections for INDs/NDAs/BLAs), and other project-specific clinical documentation
• Ensures quality and compliance of PSI-developed Essential Documents with applicable QSDs, pertinent regulatory requirements, and client specifications
• Critically assesses, interprets, and summarizes data from clinical studies
• Reviews scientific literature and client source documents pertinent to medical writing activities
• Develops and maintains templates for study-specific documents and guidelines, conforming to client and regulatory requirements (as assigned by the Director or Associate Director, Medical Writing)
• Acts as a primary or secondary contact for the client and/or the sponsor (if not the same entity), and other PSI functional areas within the scope of assigned medical writing tasks

Qualifications

• College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life science fields, or a PhD degree in medical/ journalism fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
• Minimum 2 years of corresponding industry experience working with clinical documentation and data
• Prior pharmaceutical, biotechnology, or contract research organization experience
• Excellent knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
• Industry experience in preparation of ICH E3 compliant Clinical Study Reports (CSRs) and related documents

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.