Regulatory Operations Specialist (Contract) (Human Resources)
Job Description:
Company Overview
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.
Position Summary
Reporting to the Senior Manager of Regulatory Operations, the Regulatory Operations Specialist contributes to daily operations activities for preparation and archive of global regulatory submission documents and input of metadata to Veeva RIM system. This includes operational tasks associated with or in support of document compliance (eCTD readiness review/submission readiness standards) including Word formatting, PDF publishing (including bookmarking hyperlinking and PDF auditing), production (paper and electronic compilation), distribution and electronic archiving. Depending on level of experience, may also be responsible for contributing to the development of standard processes related to regulatory submission processes. This can include developing or revising templates and developing processes/procedures to ensure compliance with global regulations.
Responsibilities
Assist in the day-to-day procedures used to support regulatory submission and publishing activities. Will also work closely with Regulatory Operations submission and document managers.
• Performs document and submission level QC for compliance with regional/ICH guidelines and internal procedures/instructions.
• Performs document publishing activities, including formatting Word documents and PDF publishing activities.
• Archives various documents and dispatched submissions in a timely manner and ensures appropriate metadata is inputted to Veeva RIM system.
• Supports distribution to submission team lists and other departments as requested.
• Assist Regulatory Operations submission manager with tracking, metadata input or routing submission-compliant document deliverables for signature, submission compilation and publishing
• Assists with various projects as assigned by direct supervisor.
• Depending on Veeva RIM experience and or Word/PDF experience, may be asked to troubleshoot users' system or document issues.
• Depending on existing or gained regulatory operations experience, may assist with authoring or contributing to various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, document compliance or electronic submission processes.
Minimum Qualifications
• Certificate, Associate's degree or higher
• 3+ years relevant document preparation experience for submission compilation to regulatory agencies to investigational or marketing applications.
• Intermediate-level knowledge of current eCTD regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to prepare and QC regulatory documents.
• Must be highly proficient in MS Word, Adobe Acrobat (version 5.0 or higher), Toolbox Pharma Adobe plug-in and StartingPoint.
• Must be proficient with Veeva Regulatory Vault.
• Able to meet tight timelines, multi-task projects and able to adapt to change.
• Detail oriented, proactive, flexible and self-starting.
Preferred Qualifications
• Experience with processing IND Safety Reports.
Competencies
• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
