Clinical Trial Disclosure Associate (Clinical Trial Registries)

Candidates can be remote, located anywhere in the US.

The duration of the contracts will be 12 months.

Responsibilities:

• May support global study registrations, writing scientific study results, protocol/result lay summaries, or anonymizing clinical documents for public disclosure by regulatory agencies.
• Responsibilities will vary based upon business need.
• Responsibilities will be focused on supporting EU CTR applications and documentation. Familiarity with clinical study and site start up documentation is preferred.
• Completes activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
• Continually trains/is compliant with all current SOPs & work instructions.
• Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
• Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
• Communicates deliverables, process and timelines effectively across functional areas and within department to accomplish project objectives.
• Holds team members accountable to agreed-upon project dates.
• Coordinates the review, approval, and other appropriate functions.
• Identifies conflicts and resolves or elevates them to management to ensure resolution.

Experience / Qualifications:

• Works well in a global, team environment
• Project management experience preferred
• Attention to detail. Find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
• Bachelor's degree required, preferably in a health or biological science field
• 2 years of writing experience preferred
• Proficient with major Microsoft suite programs and other pharma systems
• Ability to shift daily priorities, meet deadlines, ask questions
• 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