Hiring Organization / Company: Regeneron
Basic Salary: To Be Discussed
Employement Type: Full-Time
The Scientific Writing and Regulatory Liaisons group is seeking a Temp, Associate Scientific Writer to Independently author clinical pharmacology reports across various therapeutic target areas (Cardiovascular & Metabolism, Oncology, General Medicine, Immunology & Inflammation) in all phases of clinical development (Phase 1 through Phase 3).
A Typical Day in the Role of Temp, Associate Scientific Writer Might Look Like:
Provide editorial support, with a focus on clarity, accuracy, and consistency while maintaining adherence to proper format and regulatory requirements for quantitative pharmacology reports and memos
Lead efforts to coordinate multiple documents for a regulatory submission by working with subject matter experts to senior management personnel
Adhere to a report process flow and alert appropriate personnel if a process change or delay occurs
Initiate and manage multiple rounds of document review and ensuing revisions by proactively interacting with all levels of reviewers from subject matter expert to senior management
Take direction well and assume responsibility for the completion of the assigned work
Abide by GLP, GCP, and all company SOP's pertinent to the position
Keep current with software and regulatory guidances necessary for execution of job responsibilities
This Role Might Be For You If:
- You have strong attention to detail, establishing priorities and scheduling
- You are an excellent interpersonal and communication (verbal and written) skills
- You have a demonstrated ability to work effectively in a flexible environment
- You can work independently, take initiative and complete tasks to meet deadlines
This role requires a BS/MS in a Scientific field and 0-3 yrs proven experience. Ideal candidate must be Proficient in preparing accurate, written reports, have a Basic background in the life sciences, and strong attention to detail. Must demonstrate establishing priorities and scheduling and possess excellent interpersonal and communication (verbal and written) skills. The ability to work independently, take initiative and complete tasks to meet deadlines is a must. Computer proficiency (Word, Excel, Adobe and related software) and fluency in the English language is required. A basic understanding of the eCTD and the drug development process is a plus. GLP experience is a plus as is previous experience with biotechnology-derived compounds also a plus.
Job Location Information:
Location: Tarrytown, Ny 10591
Date Posted: 2021-07-21
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