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.
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 meetings.
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 preferred.
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 systems.
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: Rose@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00486
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
