Education:
•An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.
•RAC certification is beneficial.
Technical Experience:
•3+ years industry experience
•Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project.
•Familiarity with regulatory document management systems, such as Veeva Vault.
•Experience with regulatory submissions and understanding of global regulatory standards.
Knowledge, Skills, and Abilities:
•Strong foundation in medical writing, regulatory writing, and interpretation of scientific content.
•Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions.
•Effective written and verbal communication skills, with the ability to communicate complex scientific and regulatory information clearly and concisely.
•Exceptional project and time management skills, with the ability to prioritize multiple projects and adjust timelines proactively.
•Patient and empathetic approach, especially in cross-cultural and client-facing environments.
•Positive attitude toward feedback and a willingness to apply it for continuous improvement.
•Strong critical thinking and data analysis skills to ensure scientific claims align with evidence and regulatory requirements.
•High attention to detail, ensuring alignment and accuracy across multiple document reviews.
ESSENTIAL FUNCTIONS :
Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
