RA - Principal Regulatory Writer - Clinical
RA - Principal Regulatory Writer - Clinical
Posted on :
27-01-2025
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1 Vacancy
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Job Description
Job Title: R&A Principal Regulatory Writer (PRW) Clinical
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 approval process for our clients. The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The PRW will be the project lead on smaller projects interfacing directly with the client but also support larger more complex engagements as a member of a larger delivery team.
Responsibilities
Responsibilities
Qualifications
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 approval process for our clients. The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The PRW will be the project lead on smaller projects interfacing directly with the client but also support larger more complex engagements as a member of a larger delivery team.
Responsibilities
Responsibilities
- Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
- Lead a project team and actively participate in development and writing of highquality documents (studylevel and submission level documents pharmacovigilance documents)
- Author documents per client specifications templates style guides and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
- Practice blameless problem solving taking broad perspectives in resolving issues to prevent negative impact to work
- Manage budget for a low complexity project including all contributors (writers editors)
- Usher documents through the review process conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
- Maintain collaborative proactive and effective communication with both client and internal teams
- Lead projectrelated meetings and teleconferences
- Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
Qualifications
- Bachelor’s degree (minimum)
- 10 years of regulatory writing experience with clinical related documentation
- Understands regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level pharmacovigilance)
- Strong understanding of the document creation process and of the drug development lifecycle
- Intermediate proficiency with Microsoft Word skills (editing tools creating and modifying tables and inserting figures) and document management techniques
- Strong understanding of the document creation process and of the drug development lifecycle
- Able to synthesize data across multiple data sources and documents to create summary reports
- Expertise to provide subject matter guidance for quality document preparation document review accurate comment resolution/incorporation and document finalization
- Ability to own submissionlevel sections (clinical documents e.g. Clinical Study Reports Protocols Investigator Brochures ISS and ISE)) taking responsibility for clarity of purpose leading others toward the common goal within timeline and budget on complex projects
- Demonstrate an understanding of communication best practices coaching others on communication implications of decision making
- Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
- Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in performance
- Ability to resolve problems that arise particularly in sensitive or highpressure situations
- Possesses broad experience and technical expertise across more than one therapy area and integrates this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization
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Employment Type
Full Time
Key Skills
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