Medical Writer - Senior Regulatory Writing Specialist (English) Lisboa

Position Summary

Medical Writer - Senior Regulatory Writing Specialist

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.

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 to 5 years as a Regulatory Writer
• Location: Remote Portugal, Romania or Poland
• Fluent: C1 or C2 - Fluent English

Responsibilities

• 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.
• Regulatory writing: Mastery of 3 or more regulatory document types (eg, clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components).
• Project management: Manage at least 3
  - document projects simultaneously and act as a primary writer and/or project manager for key documents and projects.
• Cross-functional coordination: Organize and lead
  - functional document review meetings, clarify and incorporate feedback, and resolve unclear comments with subject matter experts.
• Quality and consistency: Ensure document accuracy, completeness, and consistency of messaging; perform
  - level QC and writer peer review.
• Process improvement: Proactively contribute to improvements to medical writing processes and update SOPs, templates, and style guides.
• Lexicons and conventions: Develop
  - level lexicons and conventions; contribute to regulatory document standards.

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.
• Regulatory understanding: 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 actions.
• Accuracy - Ability to perform work accurately and thoroughly.
• Analytical Skills - Ability to use thinking and reasoning to solve a problem.
• Detail-Oriented - Attention to minute details of a project or task.
• Self-Motivated - Internal drive to perform tasks well.
• Organized - Systematic in performing tasks.
• Tactful - Maintain good relations with others.
• Problem Solving - Proactive solution finding; project management ability to complete on time.
• Active Listening - Attentive to comments and questions of others.
• Customer-Oriented - Focus on client needs within company procedures.
• Communication, Written - Clear and concise writing.
• Communication, Oral - Clear spoken communication and ability to present information to clients.
• Applied Learning - Engages in learning activities effectively.
• Working Under Pressure - Ability to complete tasks under stress.
• Time Management - Prioritizes tasks and delivers on time.
• Work Ethic - Motivated, responsible, professional, inclusive, and proactive.
• Behavior and Attitude - Treats others with respect and maintains a positive attitude.
• Self-Motivated - Internal drive to perform tasks well.

Skills and Abilities

• Education: Advanced degree in a scientific discipline or relevant work experience; or equivalent.
• Experience: More than 2 years (typically 3-5 years) of experience in scientific/medical/regulatory writing in the pharmaceutical domain.
• Computer Skills: Proficiency with Microsoft Word, Excel, Power
  Point, and Outlook.

Work Environment

Remote - Europe

Disclaimer

The company has reviewed this job description to ensure essential functions and basic duties are included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. This document is not an exhaustive list of all functions, responsibilities, skills, and abilities. The company reserves the right to change this job description and/or assign tasks as deemed appropriate. This does not represent a contract of employment.

By attaching your CV/resume and/or completing an online application, you consent to the collection, processing, use, transfer (including to other countries), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy for information on your data rights.

We are an equal opportunity employer and all qualified applicants will receive consideration 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. Any unsolicited CVs or candidate profiles received without prior engagement or agreement will be considered free and carry no obligation on the part of Med Communications.