RA - Regulatory Writer II- Safety Narratives focus
RA - Regulatory Writer II- Safety Narratives focus
Posted on :
22-02-2025
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1 Vacancy
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Job Description
Job Title: R&A Regulatory Writer II Safety Narratives focus
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
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 2000 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 colead.
Responsibilities
Education Experience Training and Knowledge:
Certara bases all employmentrelated 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.
About Certara
Certara accelerates medicines using proprietary biosimulation software technology and services to transform traditional drug discovery and development. Its clients include more than 2000 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 colead.
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 nonclinical/CMC pharmacovigilance documents)
- Lead projectrelated meetings; lead a studylevel 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 followup responses
- Understand and adhere to constraints of budgets and tasks as provided by project leads
Education Experience Training and Knowledge:
- Bachelor’s degree
- 13 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 noninterventional 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.
- 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
Certara bases all employmentrelated 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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Employment Type
Full Time
Key Skills
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