Job ID 368005
PSI is a leading Contract Research Organization with more than 28 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
- 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
- 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
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.