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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