Posted on: March 19, 2023
Actively seeking a FULLY REMOTE Documentation Analyst to join
rapidly growing biopharma company in New Jersey Description: The
primary role is to support the regulatory activities for pre and
post submissions for biologic products as part of the CMC
Strategies team. The CMC documentation group is committed to
supporting the biologics network with integrity, reliability,
active engagement and cross-functional collaboration. Duties and
- Support the logistical process for regulatory submissions
including marketing applications and/or post-approval submissions
while interfacing across the companies network.
- Ensure final document compliance to make certain submission
content meets formatting requirements.
- Schedule and facilitate submission reviews and consensus
- Facilitate data verification to ensure accuracy of data
following internal SOP.
- Participate in initiatives to promote standardization of
submission process within the organization.
- Participate on various cross-functional project teams, interact
with technical experts, regulatory and other key partners both
internal and external to the company as necessary. Requirements:
- BS degree required
- Experience with regulatory submissions
- 2 - 4 years of direct pharmaceutical work experience
- Experience with MS Suite - specifically MS Word
- Experience with ADOBE
- Excellent organizational, communication and project management
skills are required along with proficient navigation of electronic
- Must be capable of working in a fast-paced changing team
environment, prioritizing multiple tasks to meet filing deadlines
and ensuring the most efficient regulatory process
- Must possess the ability to support multiple projects About
Actalent: Actalent connects passion with purpose. Our scalable
talent solutions and services capabilities drive value and results
and provide the expertise to help our customers achieve more. Every
day, our experts around the globe are making an impact. We're
supporting critical initiatives in engineering and sciences that
advance how companies serve the world. Actalent promotes consultant
care and engagement through experiences that enable continuous
development. Our people are the difference. Actalent is an
operating company of Allegis Group, the global leader in talent
solutions. The company is an equal opportunity employer and will
consider all applications without regards to race, sex, age, color,
religion, national origin, veteran status, disability, sexual
orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Actalent, Raleigh , Documentation Analyst, Professions , Raleigh, North Carolina
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