Company: Alpha Consulting
Location: New Brunswick
Posted on: March 17, 2023
DOCUMENTATION ANALYST (REMOTE) Project Description:
- The primary role is to support the regulatory activities for
pre and post submissions for biologic products as part of the CMC
- The CMC documentation group is committed to supporting the
biologics network with integrity, reliability, active engagement
and cross-functional collaboration.
- Support the logistical process for regulatory submissions
including Marketing applications and/or post-approval submissions
while interfacing across the Client 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. Required 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.
- Demonstrate commitment to excellence and bring a high energy
level to daily activities as well as periods of high intensity work
under tight timelines. This 6+ month position starts ASAP. Please
E-MAIL your resume (attachment to email) with rate and availability
to Rose: ALPHA'S REQUIREMENT #23-00486 MUST BE ELIGIBLE TO WORK IN
THE U.S. AS AN HOURLY W2 EMPLOYEE
Keywords: Alpha Consulting, New Brunswick , Documentation Analyst, Professions , New Brunswick, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...