What are the responsibilities and job description for the Documentation Specialist position at Actalent?
Description
Responsible for the creation and compilation of quality Regulatory submissions and life cycle management submissions Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into RA file room and electronic document management system) within specified time frames. Electronic Document Publishing (i.e., scanning, bookmarking/linking, and document verification,) Verification of regulated documents via workflows within electronic document management systems. Adherence to required submission timelines, complex publishing, and archiving of regulated documents. Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA. Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, etc. May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
Skills
document control, documentation control, regulatory compliance, electronic document management system edms, document verification
Top Skills Details
document control
Additional Skills & Qualifications
Document control document prepparation Support Regulatory personnel
Experience Level
Intermediate Level
Pay and Benefits
The pay range for this position is $40.00 - $45.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Morristown,NJ.
Application Deadline
This position is anticipated to close on Mar 19, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $40 - $45
