Randstad Pharmacovigilance in Cambridge, Massachusetts
salary:$39.57 - $46.55 per hour
date posted:Friday, July 13, 2018
PV Compliance & Training Manager I
True Title: GDS Compliance Process and Standards
Please note this is NOT a training role. True job title is GDS Compliance Process and Standards (GxP regulations, SOPs). This is a 6-month role
Review of existing policies, standard operating procedures (SOPs), job aids, training content and other types of controlled documents to identify gaps and inconsistencies for Global Drug Safety (GDS) within R&D, documentation of findings, and assist with updates to the documents as required.
Review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.
Perform Quality Control reviews on process document content and formatting to identify any gaps.
Maintain the documentation related to gaps identified in the procedural documents.
Work with subject matter experts and key functional department personnel to ensure accurate content of required documentation. Recommend revisions or changes in scope, formatting, and content as identified.
Maintain and coordinate activities related to the document update using the electronic document management system (EDMS) including document initiation, workflow support, revision, and retirement, as required.
Education & Qualifications
Minimum of five (5) years of experience writing controlled documentation in the biotechnology or pharmaceutical industry
Direct experience in GXP-compliant quality systems is preferred
Experienced in Microsoft office applications specifically Word, Excel and Visio
Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes
Excellent communication skills including: technical writing, interpersonal and
Excellent organization skills with the ability to stay accountable to deliverables and milestones
Ability to thrive and multi-task in a fast-paced environment
Must have in-depth knowledge and understanding GXP regulations, and controlled document management principles
Must work effectively in a team environment and with individuals at all levels within an organization.
This is a 6 month contractual opportunity.
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.