At NSF International, our mission is to protect and improve human health. We're a global leader in standards development, testing, auditing, certification and training. We provide these services for a diverse set of industries including food, water, healOur nearly 3,000 employees provide services in over 170 countries through our many global offices, at our client sites, from home offices and in state-of-the-art laboratories. We're growing fast, and that's where you come in. Come join our team.POSITION SUMMARY: The Protocol Writer performs all activities related to development, preparation, writing, reviewing, and editing of clinical trial protocols and related materials for submission to clients, the FDA, and other regulatory agencies.
RESPONSIBILITIES:
Write clinical trial protocols with reference to current research and FDA guidelines, with supervision from the project team.
Work with internal study teams and clients to determine/clarify project requirements and obtaining necessary information.
Coordinate the distribution of draft and final protocols to relevant study team members.
Assist in the development of standardization methods for protocol writing.
Interact with various departments to collect information and synthesize it into documents.
Keep updated guidelines and requirements of the FDA, and other regulatory agencies for reference in the development of clinical protocols for various indications, including ICH Guidelines.
Perform literature searches to aid in the development of various protocol sections.
Work with internal study teams to create therapeutic specific protocol templates.
Write, review, and QC informed consent forms (ICFs).
Prepare clinical documents to support all phases of clinical product development.
Prepare/integrate tables, graphs, and graphics for publications.
Act as a member of study, clinical project, and interdepartmental project teams.
Other duties as assigned.
REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's degree in science-related field and two (2) years related clinical experience or equivalent education and experience.
Minimum two (2) years experience in writing and preparation of clinical trial protocols phase I through III and regulatory submissions is preferred. Strong verbal and written communication skills and strong analytical skills.
Strong Microsoft Office skills particularly in MS Word and Excel.
Extremely detail-oriented with excellent follow-up skills.
Ability to work independently with minimal supervision.
Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere.
