Regulatory Writer II - Clinical
Certara
Amsterdam, NH, NL
6 dagen geleden

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 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
  • Education, Experience, Training, and Knowledge :

  • Bachelor’s degree
  • 1-3+ years of regulatory writing experience or equivalent experience
  • Knowledge of a range of documents (some examples : investigator’s brochures, protocol, CSR, pharmacokinetic reports, 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
  • 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
  • Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law.

    All employment is decided on the basis of qualifications, merit, and business need.

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