Job Description
Job Title: Regulatory Operations Senior Publisher - Contractor
Location: Florham Park, New Jersey
Type: 12-month contract (renewable)
Compensation: $40 - $57 hourly
Contractor Work Model: Hybrid
Must be local. Office presence required 10 days a month onsite. Notes: This position is specific to publishing activities for drug applications
(doesn’t need to have formatting experience). Must have
been part of an IND, sNDA or NDA to be considered for the Sr level position
. Preferring at least 2-3 years of dedicated publishing experience!
Overview: This role
will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare and file non-eCTD submissions to ensure compliance with applicable laws and regulations. This includes publishing regulatory documents, managing document tracking and version control, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvement.
Responsibilities: - Support in the preparation and submittal of regulatory applications and ongoing application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (e.g., IND, NDA/BLA, MAA, CTA, DMF).
- Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions).
- Provide technical expertise to cross-functional teams on structure of compliant documents for electronic submissions.
- Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to obtain the necessary information to ensure timely submission of regulatory documents.
- Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
- Perform quality control checks on documents to ensure accuracy and completeness, as well as resolve any issues that arise.
- Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions.
- Maintain knowledge of local regulatory submission requirements.
- Ensure adherence to Company Standard Operating Procedures.
- Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives.
- Supports in the review of Regulatory Operations processes (SOPs, work instructions, checklists, templates) for preparing submissions and regulatory information management.
- Other duties as assigned.
Minimum Job Requirements Qualifications - Minimum of 1-2 years of experience required within a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs. Prior knowledge of CTAs/MAAs a plus.
- Bachelor’s degree preferred
- Acquired knowledge of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents.
- Familiar with regulatory guidelines, such as FDA, EMA, MHRA, and Health Canada. Knowledge and understanding of relevant Health Authority guidance and other regulatory requirements
Competencies - Proficient in using:
- MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system
- Veeva Vault RIM
- ESG Gateway
- Capable of reviewing documentation with a high degree of attention to detail.
- Effective communicator adept at communicating with cross-functional teams, regardless of level
- Adept at handling and prioritizing multiple projects/activities simultaneously while ensuring all deadlines are met.
- Ability to work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance in a team-oriented environment.
- Capable of managing time effectively, prioritize tasks in order to meet objectives in a timely manner.
- Adept at identifying issues and propose solutions as necessary.
Other Requirements - No travel is required in this position
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Ref: #568-Clinical
Job Tags
Hourly pay, Contract work, For contractors, Local area,