GMP Policy Compliance Writer
As a member of the Bulletproof family, you’ll enjoy a culture that values diversity in all things – people, work, experience levels, and much more. We tackle the toughest challenges, produce impactful results, and build solid client relationships along the way – with energy, passion, and fun. If this sounds like a good fit for you, please consider this exciting opportunity with our firm!
Scope of Work
Serve as compliance writer in the review and revision of the quality policy documents as requested.
During the document revision process, map new document content to the applicable regulations and/or guidance (based on priorities specified by client) within the client's software tool.
- Align content and directives/instruction within and across each document across the quality system.
- Structure sentences, flow, word choice, and phrasing to be in US English.
- Directly provide the relationships between PQS requirements and the associated regulations.
Contractor responsibilities to include, but may not be limited to, as requested and when appropriate:
- Participate in document revision teams to contribute, facilitate, understand areas for improvement, change drivers, and the best way to execute changes.
- Assist with document change management and facilitation of document review cycles.
- Partner closely with project lead for management of ‘mapped’ content. Consider ease of implementation, management and retrieval.
- Facilitate author and SME review process and adjudication.
- As new PQS document revisions are implemented, review the document change history and add any new requirements to the CQR Delta Tool and update PQS document references.
- Assist with hand-off of the updated CQR tool and delta tool to stakeholders up on completion.
- Partner closely with project lead to ensure alignment with project objectives and timelines.
- Develop and implement project infrastructure documentation such as project status tracking tools, reporting tools, and others as needed
- Closely review document content to ensure the information contained aligns with the intended purpose of the document
- Proofread documents for:
- Accuracy to the information/content
- Language and grammar
- Correction of ambiguous or confusing wording
- Ensure integrity of content; to not change meaning
- Incorporate other changes as identified by client
- Serve as project manager for the documents in scope, including project planning and tracking, status reporting, escalation of issues, meeting management, etc.
Requirements: The ideal candidate:
- Has been in decision making roles in quality assurance
- Has expertise in either QC analytical and/or medical device quality requirements
- Is comfortable in big pharma environments and adept at working with team members in other geographies and nationalities
- Has a passion for excellence in documentation spanning authoring/developing content to detailed wordsmithing to align and satisfy cross-functional stakeholder groups
- Is seeking a flexible, part-time engagement
- Is adept at working with senior level teams, while offering suggestions, input, and ideas