Purpose:
To effectively communicate technical information across all phases of clinical research and regulatory submissions, supporting both pipeline development and product lifecycle management.
Key Responsibilities:
- Develop, review, and edit documents for clinical studies and regulatory submissions, including protocols, Investigator’s brochure, study reports, dossiers, and responses to regulatory authorities.
- Facilitate the design and analysis of clinical studies.
- Prepare scientific abstracts, presentations, and publications to showcase the company’s research and development pipeline.
- Conduct comprehensive literature searches to support product development and decision-making.
- Create scientific communication materials.
Additional Responsibilities:
- Stay updated on industry trends, emerging scientific developments, and evolving regulatory requirements.
Skills & Competencies:
- Strong knowledge of ICH guidelines, clinical research methodologies, and statistical principles.
- Excellent communication skills, with the ability to present complex scientific data clearly and concisely.
- High attention to detail with strong documentation quality control.
- Proficient in Word, Excel, PowerPoint, and other standard software tools.
- Strong team collaboration and interpersonal skills, with the ability to manage multiple stakeholders.
Qualifications:
- Bachelor’s degree (or higher) in life sciences, clinical sciences, or a related field.
- 3 years of experience in clinical research, medical affairs, or medical writing.
- Statistical experience strongly preferred.
- Familiarity with regulatory submissions and knowledge of agency requirements (FDA, EMA) is preferred.
- Fluent in written and spoken English, with experience using standard style guides.
