Location: New Brunswick
Posted on: March 17, 2023
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 BMS 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.Additional Skills
- BS degree required.
- 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.
- Possess strong interpersonal skills and demonstrates ability to
effectively interact with business functions.
- Must possess the ability to support multiple
projects.Experience Level:Entry Level 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
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Keywords: Actalent, New Brunswick , Documentation Analyst, Professions , New Brunswick, New Jersey
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