Medical Affairs Manager [515]
Company: MEDVACON Life Sciences
Location: Foster City, CA, USA (Hybrid – On-site if local; No full remote)
Employment Type: Contract (W2 Only)
Compensation: $45/hour
Benefits: This contract role does not offer benefits
Company Overview:
MEDVACON Life Sciences partners with top pharmaceutical companies to provide expert contractors for projects in cGMP Quality, Compliance, Validation, and CSV work. This opportunity is with a leading client in Foster City, CA, offering collaboration across therapy areas and functional teams including Clinical Operations and Business Conduct.
Role Summary:
The Medical Affairs Manager will provide regulatory guidance and oversight to ensure compliance with health authority requirements impacting the Medical Affairs organization. The role also includes contributions to training, SOP development, audit support, and inspection readiness.
Key Responsibilities:
Provide guidance on regulations from health authorities such as FDA, EMA, MHRA as they relate to Medical Affairs.
Assist in developing and reviewing Medical Affairs SOPs and procedural documents.
Participate in the creation and delivery of compliance training using standard modules.
Contribute to the review and improvement of GxP role-based training plans within Medical Affairs.
Support Medical Affairs with audit preparedness and regulatory inspection readiness.
Participate in internal and external audit activities, including document review.
Qualifications:
Experience in a pharmaceutical Medical Affairs lead role.
Strong problem-solving, planning, and organizational skills.
Excellent written and verbal communication abilities.
Ability to work on a W2 contract basis.
Must be local or able to work hybrid on-site (no full remote option).
Additional Notes:
Contract position with a 40-hour work week.
Please attach a Word resume with your application.
All information submitted will be kept confidential in accordance with EEO guidelines.
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