Medical Affairs Manager

📋 Description

• Provide guidance and oversight on FDA, EMA, MHRA, and other health authority regulations relevant
• Assist with the development, review, and improvement of Medical Affairs SOPs and other procedural
• Participate in developing and delivering compliance-focused training using established training
• Support periodic assessments of Medical Affairs GxP role-based training plans and recommend
• Assist with audit readiness activities in preparation for regulatory agency inspections.
• Support internal and external routine audits, including document reviews and related compliance

🎯 Requirements

• Previous experience in a pharmaceutical Medical Affairs leadership or lead-level role is required.
• Strong understanding of Medical Affairs activities and the regulatory and compliance requirements
• Ability to interpret health authority regulations and translate requirements into practical
• Excellent written and verbal communication skills, with the ability to work effectively with
• Strong organizational and planning skills, with the ability to manage multiple priorities in a
• Excellent problem-solving and analytical abilities, with a proactive approach to identifying and

🎁 Benefits

• $45/hour compensation.
• Contract position with a 40-hour work week.
• W-2 employment arrangement.
• On-site work, with limited hybrid flexibility for candidates local to the site.
• Opportunity to work across multiple therapy areas and collaborate with teams such as Clinical
• Exposure to Medical Affairs compliance, GxP training, regulatory inspections, and audit activities.