The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville and Frederick, Maryland. Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. Emmes is seeking a Regulatory Manager .
The Regulatory Manager, Regulatory Operations Support is responsible for the overall oversight, management and operational activities for regulatory document management, including, but not limited to, controlled document management systems, electronic Trial Master Files (eTMF) and electronic submissions (e-submissions).
Essential Document Management:
Provide Corporate and project-specific eTMF (Veeva Vault) Support
Act as an administrator of the Veeva Vault eTMF system, setting up and maintaining the system in conjunction with the Clinical System Analyst team
Establish and maintain company guidelines and work instructions for eTMF (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)
Lead user training (internal and external) and train-the-trainer training sessions, establishing and maintaining user reference materials for all user types and tracking trained users, user access and eTMF permissions
Track proposals and timelines for eTMF deployment, ensuring project resources are utilized appropriately given their site activation / close-out processes
Oversee and support eTMF implementation at the corporate and project levels, establishing user roles and cross-functional governance to ensure optimal utilization. Assist with optimal eTMF utilization and close out by assisting with the drafting and maintenance of paper to eTMF mapping documents responding to questions, advising on document placement, and trouble-shooting as needed
Develop and maintain eTMF and TMF SOPs and templates according to the TMF reference model
Ensure optimal use of eTMF functionality by analyzing project and industry best practices and transferring manual processes into automated workflows, as possible
Act as liaison between publishing group and projects, educating teams and leading the process to ensure the receipt of publish-ready documents within established timeframes to meet anticipated submission deadlines
Establish and implement processes for finalization and e-submission of documents to Regulatory Agencies, ensuring templates are correct and publishing is straightforward and costs are kept low
- Develop, maintain, and oversee usage of standardized document descriptions for TMF components and other essential documents, including contract deliverables, generated during product development and clinical trial conduct, based on best practices and Emmes procedures and in conjunction with Subject Matter Experts
- Develop, maintain, and oversee applicable SOPs (Project and Corporate) and templates to ensure that routine document management operations are performed in adherence with ICH/GCP/regulatory guidelines and best practices
- Establish and oversee document mapping from project team folders to archival systems, including the eTMF and other controlled electronic media, and establishing standardized document naming conventions
- Coordinate and oversee document management activities, including archiving, performed by third parties, such as vendors, clinical sites, collaborators, as well as other internal and external team members, as required
Interact with publishing vendor to manage timelines, exchange documents securely and communicate document delivery dates
PharmD or PhD in a scientific discipline, preferred along with at least 5 to 7 years of relevant experience in Regulatory Affairs. BS/MS requires 8 to 10 years of relevant work experience in Regulatory Affairs or 10+ years of experience with a BS only
RAC Certification Preferred for Regulatory Strategy Role, relevant industry association (AIIM/CQA/CfPIE) certifications for Regulatory Operations Role
Must have in-depth knowledge of U.S. FDA and International regulations, guidance documents, and regulatory process pertaining to drug development, clinical testing and approval, inclusive of CMC, clinical and non-clinical requirements / dossier content and presentation
Working knowledge of GCP and TMF governing regulations, such as the TMF Reference Model
Thorough understanding of records management best practices and core requirements and in Drug Development
Experience with the evaluation, implementation and maintenance of electronic document management systems within the pharmaceutical company setting
Experience evaluating and utilizing third party document sharing tools, such as LiveLink, FileNet, etc.
Experience in NIH-sponsored clinical programs a plus
Experience in line-management and/or mentoring less experienced Regulatory Affairs staff
Strategic thinking, leadership skills, assertiveness, strong technical background, good business judgment, integrity, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams
Thorough understanding of electronic submissions for ICH/FDA compliance to electronic Common Technical Document (eCTD) standards
Excellent organizational, planning, analytical, and problem solving skills. Attention to detail required
Ability to build and maintain positive relationships with management, peers, and subordinates. Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners
Excellent verbal and written presentation and communication skills are necessary. Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.
Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA
Consistently exercises sound judgement and effectively prioritizes competing tasks in a fast-paced and dynamic environment
Possess high degree of initiative and the ability to work independently
Sound knowledge in MS Office (Word, Excel, and PowerPoint) and PDF rendering tools
Experience in the areas of Infectious Diseases, Cellular Therapies, Ophthalmology Medicine, Substance Use Disorders, and/or Child and Maternal Health is a plus
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.
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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.