Medical Writer - Senior Regulatory Writing Specialist (English) Lisboa

Overview

Medical Writer - Senior Regulatory Writing Specialist (English) role at Med Communications. This position focuses on creating regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices, working with client teams to manage regulatory writing projects.

Essential Qualifications

• Degree: 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: At least 3 to 5 years as a Regulatory Writer.
• Location: Remote Portugal, Romania or Poland.
• Fluent: C1 or C2 - Fluent English.

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.

• Regulatory writing skills with mastery of 3 or more regulatory document types (e. g. , clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components).
• Solid understanding of and ability to apply the statistical, regulatory, and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area. Manages at least 3
  - document projects simultaneously.
• Working knowledge of relevant regulatory guidance (e. g. , ICH, FDA, EMA) for clinical trial conduct, including
  - specific guidance; core
  - functional clinical research roles and procedures, and how they relate to document preparation. Acts as a primary writer and/or project manager for key documents and projects.
• Ensures document accuracy, completeness, and consistency of messaging. Organizes and leads
  - functional document review meetings, clarifies and incorporates feedback, and works with
  - functional subject matter experts to resolve unclear comments and differences of opinion between functional areas.
• Performs
  - level QC (abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc. ) and writer peer review (logical flow, sense check, etc. ).
• Leads
  - level management activities, including timeline preparation and oversight and meeting scheduling. Guides less experienced writers on documents within their expertise.
• Proactively contributes to improvements to medical writing processes.
• Understands, complies with, and contributes to updates of SOPs, templates, best practices, policies, and regulatory writing style guides.
• Develops
  - 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 able to quickly 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: 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.

Compliance and Policies

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 CV/resume and/or completing an online application, you consent to the collection, processing, use, transfer (including 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: Recruitment agencies should avoid unsolicited CVs; our
- house team manages all hiring processes. Any unsolicited CVs or candidate profiles received without prior engagement or agreement will be considered free and carry no obligation. We will reach out to preferred partners proactively if collaboration opportunities arise.

Additional information

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Marketing, Public Relations, and Writing/Editing

Industries: Business Consulting and Services