R&A - Regulatory Writer II- Safety Narratives focus

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

Job summary

A leading company in biopharmaceutical services seeks a Regulatory Writer II to contribute to regulatory document authorship and project leadership. The role involves preparing high-quality submissions, participating in project teams, and ensuring effective communication in a collaborative environment. Candidates should have a bachelor's degree and relevant experience in CSR narrative writing.

Qualifications

• 1-3+ years of CSR narrative writing experience.
• Knowledge of a range of documents in drug development.
• Understanding of ICH guidelines for patient safety narratives.

Responsibilities

• Author documents per client specifications and guidelines.
• Lead project-related meetings and maintain communication.
• Review a variety of documents including CSR narratives.

Skills

Microsoft Word

Communication

Time Management

Data Analysis

Collaboration

Education

Bachelor’s degree

Job description

Social network you want to login/join with:

R&A - Regulatory Writer II- Safety Narratives focus, united kingdom

col-narrow-left

Client:

Certara

Location:

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

24b4f199debc

Job Views:

5

Posted:

02.06.2025

Expiry Date:

17.07.2025

col-wide

Job Description:

Overview

About Certara

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

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

Responsibilities

Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or Senior Regulatory Writer

Author documents per client specifications, templates, style guides, and other guidance documents

Review a variety of documents (including but not limited to CSR narratives, clinical, non-clinical/CMC, pharmacovigilance documents)

Lead project-related meetings; lead a study-level document, understand how the budget affects the tasks and how resourcing works

Maintain collaborative, proactive, and effective communication with both client and internal teams

Lead a comment resolution meeting (CRM) with little support, complete appropriate preparation documents and compile appropriate follow-up responses

Understand and adhere to constraints of budgets and tasks 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 a range of documents (some examples: CSR narratives, investigator’s brochures, protocol, CSR, observational and non-interventional reports, method validation reports, stability reports, lay summaries)

Possess an understanding of the drug development process

Possess technical regulatory knowledge to understand client technical requirements and needs

Possess working knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), E3 guidelines for the development patient safety narratives.

Skills & Abilities:

Intermediate proficiency with Microsoft Word skills(editing tools, creating and modifying tables and inserting figures) and document management techniques

Understand the fundamental aspects of communication theory and practice; demonstrate an understanding of analyzing data and presenting in a written format.

Effectively build support and consensus in support of a quality work product

Communicate clear, concise, and relevant information in a professional manner

Ability to work in a collaborative environment, openly share information, and willingly contribute toward accomplishment of team goals

Action and detail oriented, always seeking new development opportunities to build knowledge and skills

Demonstrate solid time management skills

Show flexibility to meet project needs as required by deadlines and meet corporate goals and objectives

Remain knowledgeable of changes in the industry and adapting best practices

EEO

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.