Regulatory Writing Associate
- Hiring from
- Portugal
- Work type
- Remote
- Posted
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REGULATORY WRITING ASSOCIATE
The Regulatory Writing Associate is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual will work under the guidance of a manager or trainer to support regulatory writing projects.
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements:
- With support, serve as lead writer on regulatory documents (e.g., protocols, CSRs, IB updates).
- Manage timelines and communications for writing projects.
- With support, organize and lead document review meetings with cross-functional teams, clarify and incorporate feedback.
- Ensure clarity, consistency, and accuracy across all assigned deliverables.
- Perform document-level quality control review (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and contribute to peer reviews (logical flow, sense check etc.).
- Collaborate with subject matter experts to resolve feedback and align messaging.
- Understand and comply with SOPs, templates, best practices, policies, and regulatory writing style guides.
- Develops project-level lexicons and conventions.
Position Qualifications:
- Above average attention to detail, teamwork, and initiative.
- Ability to interact with other departments within the company and be proficient in written and verbal communication.
- Proficient in Microsoft Word, Power Point, and Outlook, and quickly able to learn new software.
- Ability to apply regulatory guidelines to content development.
Skills and Abilities:
- Education: Advanced degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience.
- Experience: Up to 1 year of related experience in scientific/medical/regulatory writing in the pharmaceutical domain.
- Computer Skills: Proficiency with Microsoft Word, PowerPoint, and Outlook.
- Availability: Available to work within US time zones and business hours.
Disclaimer
The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described.
It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
