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 lay 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 Required
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