Medical Affairs - Documents Specialist

Company: Intelliswift Software
Location: San Mateo
Posted on: June 16, 2022

Job Description:

Job DescriptionManager, Medical Affairs Operations Compliance Associate (Grade 28)
Specific Job Requirements
--- Provide guidance and oversight related to health authority (FDA, EMA, MHRA, etc.) regulations that impact the Medical Affairs organization.
--- Must have a very good attention to detail and demonstrate the ability to consistently meet the high standards required in Compliance deliverables.
--- Ability to consistently discern area(s) requiring input from Compliance, Quality and Pharmacovigilance business partners.
--- 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.
--- Foster commitment to quality in individuals and a culture of quality within the organization
Knowledge/Skills
--- Demonstrated excellence in working independently
--- Demonstrated success in managing multiple, simultaneous, complex projects
--- Demonstrated excellence in providing compliance related guidance and establishing effective working relationships with internal and external key stakeholders
--- Demonstrated excellent communication and problem-solving skills
--- Demonstrated excellence in supervising the tasks of more junior employees
--- Demonstrated success in making and implementing improvements to the operations of a function
--- Demonstrated success in giving formal presentations to internal groups or departments
--- Excellent proficiency in Microsoft Office applications
Education and Experience
--- BS/BA and 7 years or MS/MA and 4 years of relevant experience
--- Minimum 5 years of relevant experience in the pharmaceutical or health care industry preferred
--- Thorough understanding of *** products and all relevant departmental and corporate policies and processes preferred: 22-07668 : Foster City, CA:

Keywords: Intelliswift Software, San Mateo , Medical Affairs - Documents Specialist, Healthcare , San Mateo, California