Associate Medical Writer

PSI CRO; United States; On-site; USD 70,000 - 90,000; Full time

Job summary

A leading global clinical research organization is seeking experienced professionals for medical writing roles. Candidates should have a bachelor's or master's degree in biomedical or life sciences, along with at least 2 years of experience in medical and regulatory writing. The role involves writing, editing, and reviewing clinical documentation, collaborating with project teams, and ensuring quality control. This is an opportunity to showcase your skills within a supportive and dynamic work environment.

Qualifications

• Minimum 2 years of experience in medical and/or regulatory writing.
• Experience with clinical documentation and data.
• Knowledge of FDA, ICH regulations.

Responsibilities

• Write and review clinical documentation.
• Finalize clinical study report narratives.
• Perform quality control reviews of documents.
• Collaborate with teams on patient safety narratives.

Skills

Medical writing

Regulatory writing

Clinical documentation

Quality Control

Education

Bachelor's or Master's degree in biomedical or life sciences

Job description

Overview

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.

Responsibilities

• 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.