Regulatory writer i (clinical trial disclosure)Certara

Job Title: Regulatory Writer I
Reports to: Regulatory Services Manager (or higher)
Business Unit: Regulatory Services
Location: Makati City, Philippines
Job Overview:
Regulatory Writers provide support on the development of high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Regulatory Writer I (RW I) will support senior writers in the creation of a variety of documents across different service lines. The RW I will provide scientific insight and analysis while developing a broad scientific knowledge base in the pursuit of a successful project. #LI-BE1
Responsibilities:
Participate on project teams that may be led by a Principal Regulatory Writer, Associate Principal Regulatory Writer, or Senior Regulatory Writer
Author documents or sections of documents per client specifications, templates, style guides, and other guidance documents under the direction of a senior writer
Support review for a variety of documents
Usher documents through the review process
Participate in project-related meetings and provide meetings minutes to participants
Participate in comment resolution meetings (CRMs), 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 in English, Journalism, Scientific discipline or related field with an interest in regulatory writing
1-3 years of prior related experience; highly skilled, talented, and motivated candidates will be considered
Strong computer skills, including proficiency with MS Office and Microsoft Word functionality in terms of editing tools, creating and modifying tables and inserting figures
Prefers MDs, Licensed Nurse or Pharmacist
Skills & Abilities:
Understand the fundamental aspects of communication theory and practice
Communicate clear, concise, and relevant information in an appropriate business format
Ability to work in a collaborative environment and be tolerant of some degree of ambiguity, easily build relationships with others
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 adapt best practices
OTHER INFORMATION:
Number of Employees Supervised: Not Applicable
Percentage of Travel Required: Not Applicable
Special Requirements:
Certara

Manila City, Metro Manila Makati City, Metro Manila
Permanent
Full-time