R&A - Regulatory Writer II- Safety Narratives focus
Client:
Certara
Location:
United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
24b4f199debc
Job Views:
4
Posted:
13.02.2025
Expiry Date:
30.03.2025
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
1. Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or Senior Regulatory Writer.
2. Author documents per client specifications, templates, style guides, and other guidance documents.
3. Review a variety of documents (including but not limited to CSR narratives, clinical, non-clinical/CMC, pharmacovigilance documents).
4. Lead project-related meetings; lead a study-level document, understand how the budget affects the tasks and how resourcing works.
5. Maintain collaborative, proactive, and effective communication with both client and internal teams.
6. Lead a comment resolution meeting (CRM) with little support, complete appropriate preparation documents and compile appropriate follow-up responses.
7. Understand and adhere to constraints of budgets and tasks as provided by project leads.
Qualifications
Education, Experience, Training, and Knowledge:
1. Bachelor’s degree.
2. 1-3+ years of CSR narrative writing experience within the past year of this job posting.
3. 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).
4. Possess an understanding of the drug development process.
5. Possess technical regulatory knowledge to understand client technical requirements and needs.
6. 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:
1. Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques.
2. Understand the fundamental aspects of communication theory and practice; demonstrate an understanding of analyzing data and presenting in a written format.
3. Effectively build support and consensus in support of a quality work product.
4. Communicate clear, concise, and relevant information in a professional manner.
5. Ability to work in a collaborative environment, openly share information, and willingly contribute toward accomplishment of team goals.
6. Action and detail oriented, always seeking new development opportunities to build knowledge and skills.
7. Demonstrate solid time management skills.
8. Show flexibility to meet project needs as required by deadlines and meet corporate goals and objectives.
9. 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.
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Created on 13/02/2025 by TN United Kingdom
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