Medical Writer - Senior Regulatory Writing Specialist
Medical Writing - Regulatory Writing - Regulatory Affairs
Essentials:
Degree: Advanced degree in a scientific discipline (eg, life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience.
Experience: At least 3 years as a Regulatory Writer
Fluent: C1 or C2 - English Speaker
Europe Remote
POSITION SUMMARY
The 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 FUNCTIONS
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
- Serve as lead writer on regulatory documents (e.g., protocols, CSRs, briefing books, INDs, NDAs).
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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.).
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Collaborate with subject matter experts to resolve feedback and align messaging.
- Contribute to writing process improvements, SOP development, and best practices documentation.
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Support training or mentoring of less experienced writers on specific document types.
- Develops project-level lexicons and conventions.
POSITION QUALIFICATIONS
- Above average attention to detail, teamwork and initiative.
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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.
Competency Statements
Ethical - Ability to conform to a set of values and accepted standards.
Accountability - Ability to accept responsibility and account for his/her actions.
Accuracy - Ability to perform work accurately and thoroughly.
Analytical Skills - Ability to use thinking and reasoning to solve a problem.
Detail-Oriented - Ability to pay attention to the minute details of a project or task.
Self -Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
Organized - Possesses the trait of being well organized or following a systematic method of performing a task.
Tactful - Ability to show consideration for and maintain good relations with others.
Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
Project Management - Ability to develop and complete a project in a timely manner.
Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
Customer-Oriented - Ability to take care of client needs while following company procedures.
Communication, Written - Ability to communicate clearly and concisely in writing.
Communication, Oral - Ability to communicate effectively and professionally with others using the spoken word. Ability to present information to clients via in-person, videoconference, or phone presentations.
Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience.
Working Under Pressure - Ability to complete assigned tasks under stressful situations. Regulatory Understanding Ability to apply regulatory and compliance guidelines to pharmaceutical industry.
Time Management - Uses time effectively and productively, prioritizes tasks, delivers results on time, solves problems quickly and decisively.
Work Ethic - Highly motivated, produces consistent high-quality work, has a desire to work hard, takes responsibility, learns from mistakes, follows through with commitments, is professional, is inclusive and welcoming, has respect for others, and goes above and beyond what is required.
Behavior and Attitude - Treats others with respect, projects and promotes a positive attitude, uses appropriate behavior, establishes good working relationships, resolves conflict effectively, and speaks kindly to others.
Self-Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
SKILLS AND ABILITIES
Education: Advanced degree in a scientific discipline (eg, 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.
WORK ENVIRONMENT
Remote Europe
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.
By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection.
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.
Recruitment Agency Notice:
Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes.
Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.
Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.
