- Provide guidance and oversight related to health authority (FDA, EMA, MHRA, etc.) regulations that impact the Medical Affairs organization.
- May assist in development or review of Medical Affairs SOPs and other procedural documents.
- Participates in developing and presenting training using standard modules and training on compliance related topics.
- Participates in the periodic assessment and review of Medical Affairs GxP role-based training plans to suggest improvements to existing curriculums.
- Assists in audit readiness for regulatory agency inspections
- Supports Medical Affairs with internal or external routine audit activities and document reviews.
- Ability to work hybrid if local to the site only - NO Full remote
Qualifications
Exp in a pharma Medial Affairs lead role.
Ability to work W2 only
$45 ph
Excellent written/oral communication skills.
Solid organizational & planning skills.
Excellent problem-solving skills
Additional Information
Please attach a WORD resume to your submission
All of your information will be kept confidential according to EEO guidelines.
ON-SITE only on W2
This is a contract role and does not offer benfits
40-hour week