Medical Affairs Manager [515]
AI Summary
Medical Affairs Manager provides guidance and oversight on health authority regulations (FDA, EMA, MHRA), supports SOP development/review, and participates in training and audit activities for Medical Affairs in a pharmaceutical setting.
About this role
Medical Affairs Manager [515]
MEDVACON Life Sciences works with many leading pharmaceutical companies to hire contractors for projects & assignments in cGMP Quality, Compliance, Validation and CSV work.
We're supporting our client in Foster City CA to hire contractors for several roles. This is an outstanding opp to work with colleagues across different therapy areas and functional teams (Clinical Operations, Business Conduct, etc)
- 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
Skills
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