Job Description:
Responsibilities:
- Responsibilities will be focused on supporting EU CTR applications and documentation. Familiarity with clinical study and site start up documentation is preferred.
- Responsibilities will vary based upon business need. May support global study registrations, writing scientific study results, protocol/result Client summaries, or anonymizing clinical documents for public disclosure by regulatory agencies.
- Completes activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
- Communicates deliverables, process and timelines effectively across functional areas and within department to accomplish project objectives.
- Coordinates the review, approval, and other appropriate functions.
- Identifies conflicts and resolves or elevates them to management to ensure resolution.
- Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
- Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
- Continually trains/is compliant with all current SOPs & work instructions.
Experience / Qualifications:
- Bachelor's degree required, preferably in a health or biological science field
- 2-4 yrs experience in clinical trial registries, regulatory agency transparency or drug development with a clinical research, quality or regulatory background, preferably in a pharma environment
- Project management experience preferred
- 2 years of writing experience preferred
- Attention to detail. Find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
- Ability to shift daily priorities, meet deadlines, ask questions
- Proficient with major Microsoft suite programs and other pharma systems
- Works well in a global, team environment
Job Types: Full-time, Contract
Pay: $47.19 per hour
Expected hours: 40.00 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Work Location: Remote