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Medical Affairs Manager [515]

Role overview

Qualifications

  • Experience in a pharma Medical Affairs lead role
  • Ability to work W2 only
  • Excellent written/oral communication skills
  • Solid organizational planning skills

Responsibilities

  • Provide guidance and oversight related to health authority regulations impacting the Medical Affairs organization
  • Assist in development or review of Medical Affairs SOPs and other procedural documents
  • Participate in developing and presenting training on compliance related topics
  • Assist in audit readiness for regulatory agency inspections

Key facts

  • Remote from: United States
  • Fixed term
  • Senior (5-10 years)
  • Medical Affairs Manager
  • English

Hard skills

Other skills

  • Training And Development
  • Communication
  • Organizational Skills
  • Problem Solving

About the company

MEDVACON LIFE SCIENCES, LLC logo

MEDVACON LIFE SCIENCES, LLC

  • Pharmaceuticals
  • SME
  • 51–200
MEDVACON is a renowned company recognized globally for providing tailored FDA Quality Compliance and Technical Consulting Services. With an unwavering commitment, MEDVACON partners with Life Sciences Companies to achieve optimal solutions while effectively managing compliance-related expenditures. MEDVACON’s extensive array of services reflects our dedication to client satisfaction. Our proficiency encompasses Validation, Qualification, Quality Systems, IT Computer System Validation/Software Quality Assurance (CSV/SQA), FDA Audit Preparation, Response and Remediation Services, as well as Training, Tech Transfers, and Project Management. We look forward to partnering and working with you and your organization! MEDVACON, Elevating Excellence

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Job description

Company Description

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)

Job Description

  • 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

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