Medical Writer - Senior Regulatory Writing Specialist

Medical Writer -Senior Regulatory Writing SpecialistPOSITION SUMMARYThe Medical Writer -Senior Regulatory Writing Specialist 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 directly with client teams to manage regulatory writing projects.
ESSENTIAL FUNCTIONSTo 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
Serve as lead writer on regulatory documents (e.G., protocols, CSRs, briefing books, INDs, NDAs).
Manage timelines and communications for at least three concurrent writing projects.
Organize and lead document review meetings with cross‑functional teams, clarify and incorporate feedback, work with cross‑functional subject matter experts to resolve unclear comments and differences of opinion between functional areas.
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.
Contribute to writing process improvements, SOP development, and best practices documentation.
Support training or mentoring of less experienced writers on specific document types.
Develop 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, Excel, Power Point, and Outlook, and quickly able to learn new software.
Ability to apply regulatory guidelines to content development.
SKILLS AND ABILITIESEducation:
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:
More than 2 years (typically 3-5 years) of experience in scientific/medical/regulatory writing in the pharmaceutical domain. Mastery of 3 or more regulatory document types.
Computer Skills:
Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
WORK ENVIRONMENTRemote - Europe
DisclaimerThe 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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.
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