Summary
Location
United States
Type
full-time
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About this role
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
- Writes, edits, and reviews documents, including informed consent forms, patient information, and other project-specific clinical documentation.
- Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives.
- Collects and tracks documents for CSR appendices, in support of the Quality Control Associates.
- Performs quality control (QC) reviews of PSI-developed documents, in support of the Quality Control Associates.
- Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks.
- Collaborates with the Process Improvement narrative automation team to develop patient safety narratives.
Qualifications
- College or university degree, preferably a Bachelor's or Master's degree in biomedical or life sciences fields, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities. Equivalency is defined as a minimum of 2 years of experience in medical and/or regulatory writing and related tasks.
- Minimum 2 years of corresponding industry experience working with clinical documentation and data
- Prior pharmaceutical, biotechnology, or contract research organization experience
- Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of documents
- Basic knowledge of electronic Common Technical Document (eCTD) requirement
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.
Other facts
About PSI CRO
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
What you'll do
- The Associate Medical Writer is responsible for writing, editing, and reviewing clinical documentation, including informed consent forms and clinical study reports. They also perform quality control reviews and collaborate with teams to develop patient safety narratives.
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