Assistant Project Manager Medical Affairs
1 day ago
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.
Tell employers what skills you have
Excellent Communication Skills
Team Collaboration
Microsoft PowerPoint
Quality Control
Clinical Research
Medical Writing
Product Lifecycle Management
Research and Development
Medical Affairs
Medical Communications
Attention to Detail
Publications
Product Development
Regulatory Requirements
Life Sciences
Regulatory Submissions
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