Job Role: Data Remediation Subject Matter Advisor
Remote
Long Term
Required Skills:
Records Management experience in pharma companies
Experience in divestiture requirements and regulatory compliance including review of sensitive information
Participate in global divestitures in functions including R&D, Regulatory, Safety or Clinical functions
What you do:
Sample and review select documents and determine sensitivity based on defined guidelines
Help prepare and present oral and written reports and presentations to internal and external stakeholders
Develop and maintain client relationships and ensure client satisfaction
Responsibilities:
Perform scientific research and consultation for regulatory defensibility to divestiture business units for global biopharmaceutical companies
Perform systematic and methodical review of all relevant documentation and Intellectual Property using review platforms and proprietary technology and infrastructure and determine document sensitivity
Manage and execute workflows for analyzing and dispositioning relevant documents, according to legal and retention guidelines in M&A
Substantive review of scientific laboratory notebooks, manufacturing records, logbooks, SOPs and Intellectual Property documents
Education:
PhD or Advanced Degree in Chemistry, Biochemistry, or other related fields