R&A - Regulatory Writer II- Safety Narratives focus

TN United Kingdom; United Kingdom; On-site; GBP 35,000 - 55,000; Full time

Job summary

An innovative firm is seeking a Regulatory Writer II to contribute to high-quality documentation for regulatory submissions. This role involves authoring critical documents, leading project meetings, and collaborating with senior writers. The ideal candidate will have a Bachelor's degree and experience in CSR narrative writing, along with strong communication and time management skills. Join a dynamic team dedicated to transforming drug discovery and development, where your contributions will play a vital role in streamlining the documentation process for clients worldwide.

Qualifications

• 1-3+ years of CSR narrative writing experience.
• Knowledge of regulatory documents and drug development process.

Responsibilities

• Author documents per client specifications and templates.
• Lead project-related meetings and oversee study-level documents.
• Maintain effective communication with clients and internal teams.

Skills

Microsoft Word

Communication Skills

Team Collaboration

Time Management

Action-oriented Development

Education

Bachelor's Degree

Job description

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R&A - Regulatory Writer II- Safety Narratives focus, United Kingdom

Client: Certara

Location: United Kingdom

Job Category: Other

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EU work permit required: Yes

Job Reference: 24b4f199debc

Job Views: 10

Posted: 28.04.2025

Expiry Date: 12.06.2025

Job Description:

Overview

Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

About Certara

Regulatory Writers prepare high-quality documentation for regulatory submissions to help streamline the documentation process for our clients. The Regulatory Writer II (RW II) is a major contributor to document authorship, supporting senior writers in creating various documents across service lines. The RW II may serve as a backup project lead, having written sections of regulatory documents or leading projects with support from a co-lead.

Responsibilities

• Participate on project teams led by Principal, Associate Principal, or Senior Regulatory Writers.
• Author documents per client specifications, templates, style guides, and other guidance documents.
• Review various documents including CSR narratives, clinical, non-clinical/CMC, and pharmacovigilance documents.
• Lead project-related meetings; oversee a study-level document; understand how the budget affects tasks and resourcing.
• Maintain effective communication with clients and internal teams.
• Lead comment resolution meetings with minimal support; prepare documents and follow-up responses.
• Understand and adhere to budget and task constraints as provided by project leads.

Qualifications

Education, Experience, Training, and Knowledge:

• Bachelor’s degree.
• 1-3+ years of CSR narrative writing experience within the past year of this job posting.
• Knowledge of documents such as CSR narratives, investigator’s brochures, protocols, CSR, reports, and summaries.
• Understanding of the drug development process.
• Technical regulatory knowledge to understand client requirements.
• Working knowledge of ICH E3 guidelines for patient safety narratives.

Skills & Abilities

• Proficiency with Microsoft Word, including editing tools, tables, and figures.
• Understanding of communication theory and data presentation.
• Ability to build support and consensus.
• Clear, concise, professional communication.
• Collaborative team working skills.
• Action-oriented with a desire for continuous development.
• Solid time management skills.
• Flexibility to meet deadlines and adapt to industry changes.

EEO

Certara bases employment decisions on merit, qualifications, skills, achievement, and performance. All applicants and employees are treated without regard to personal characteristics protected by law.