Regulatory Publishing Specialist
Cook Medical
- Pittsburgh, PA
- Permanent
- Full-time
- Preparation, coordination / compilation of Regulatory submissions, publications, and filings to U.S. FDA and other Regulatory agencies, including but not limited to:
- Proficient in eCTD compliance; document optimization; book marking; hypertext linking; publishing;
- Management of eCTD publishing compliance to regulatory standards and requirements
- Creation and maintenance of eCTD templates based on FDA guidance documents and checklists
- Structure of Modules (1-5)
- ePADERS (Periodic Adverse Drug Experience Reports) submissions to FDA via FDA Electronic Submissions Gateway (ESG) portal; familiarity with ICSRs and FAERS portal submissions
- Creation and submission of Structured Product Labeling (SPL) for drug listing, drug establishment registration, Self ID, Labeler Codes, and more
- Archival of submissions in electronic and hard copy format; maintains up-to-date records of completed submissions and submissions in progress
- Perform Quality reviews of submissions for publishing
- Participates in the writing and reviewing of Regulatory processes (BOP, Work Instructions and internal guidelines)
- Maintains schedule of and file post-approval documentation
- Project management of submissions
- Interact with regulatory personnel and/or clients to help ensure components are received in a timely manner
- Track progress of all components and relay information to management
- Interact effectively with outside organizations to obtain necessary information
- Develop and adhere to timelines
- Undergraduate degree in any Life Sciences, or 2-4 years of direct, relevant experience in Regulatory Affairs publishing to provide a comparable background
- Minimum of 2-4 years of experience in Regulatory Affairs or GMP/GCP setting
- Knowledge of regulations and guidelines governing biological product development (particularly clinical)
- Prior experience creating technically compliant regulatory submissions using technology such as MS Word and Adobe Pro
- Advanced proficiency in MS Office, specifically, advanced knowledge of Adobe, OneNote, Excel, Word and PowerPoint
- Demonstrable knowledge of eDMS and regulatory information submission applications
- This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
- Ability to work in collaborative and independent work situations and environments with minimal supervision
- Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
- Remote position
- Travel: Less than 10%
- Ability to conduct and hear ordinary conversation and telephone communication.
- Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
- Ability to work under specific time constraints.
- Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
- Visual and manual acuity for working with computers and equipment.