• Home
  • Job
  • R&A - Principal Regulatory Writer (PRW) - Clinical

R&A - Principal Regulatory Writer (PRW) - Clinical

Certara | Thuiswerk | NL

Welcome to the Latest Job Vacancies Site 2025 and at this time we would like to inform you of the Latest Job Vacancies from the Certara with the position of R&A - Principal Regulatory Writer (PRW) - Clinical - Certara which was opened this.

If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is not easy to apply because it must meet several qualifications and requirements that we must meet in accordance with the standard criteria of the Company who are looking for potential candidates to work. Good job information R&A - Principal Regulatory Writer (PRW) - Clinical - Certara below matches your qualifications.

...

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 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 high-quality documents (study-level 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 project-related 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: Qualifications
  • Bachelors 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
Skills & Abilities
  • 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 submission-level sections (Clinical documents, e.g., Clinical Study Reports, Protocols, Investigator Brochures, Module 2.7 documents, Clinical Overview, 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 high-pressure 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
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.

Information :

  • Company : Certara
  • Position : R&A - Principal Regulatory Writer (PRW) - Clinical
  • Location : Thuiswerk
  • Country : NL

How to Submit an Application:

After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the R&A - Principal Regulatory Writer (PRW) - Clinical job info - Certara Thuiswerk above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies R&A - Principal Regulatory Writer (PRW) - Clinical job info - Certara Thuiswerk in 2025-03-02 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.

Next Process

Attention - In the recruitment process, legitimate companies never withdraw fees from candidates. If there are companies that attract interview fees, tests, ticket reservations, etc. it is better to avoid it because there are indications of fraud. If you see something suspicious please contact us: support@jobthird.com

Post Date : 2025-03-02

Recomendations Jobs