Company: Alpha Consulting Corp.
Posted on: May 23, 2023
- Technical Writing and Document Management (TDM) function is
responsible for delivering CMC documentation (Dossier and
supporting documents) to support regulatory strategy for Cell
therapy portfolio from early stage through life cycle
- Document Specialist supports the documentation activities for
regulatory submission content and supporting documentation for cell
- This role requires effective collaboration across technical
functions to deliver on timelines for submissions. The position
interfaces with experts in Process Development, Manufacturing
Sciences and Technology, Operations, Analytical Development,
Quality and Regulatory Sciences.
- The successful candidate will work effectively in
cross-functional project teams to accomplish company goals.
- Manage the logistical process and detailed timeline for CTD
Quality sections aligned with scientific/regulatory content
creation for clinical, commercial, and life-cycle CMC regulatory
submissions and responses to health authority questions.
- Assist with dossier creation and system compliance for
- Manage dossier content and agency questions delivery timelines
aligned with global CMC submission timelines.
- Must possess a thorough understanding of the source
documentation requirements needed for regulatory submissions and
the correlation to the authoring process.
- Support SMEs with document editing for compliance with the
Client authoring style guide, Core template.
- Schedule authoring, review, approval tasks and consensus
meetings with stakeholders (SMEs, GRS CMC, management).
- Facilitate data verification activities.
- Participate in initiatives involved with regulatory
- Participate in various cross-functional project teams, interact
with SMEs, regulatory and other key partners both internal and
external to the company as necessary.
- Must possess the ability to support multiple projects
- Work in a team environment and foster teambuilding for the
improvement of processes and enhancement of productivity to align
with key business drivers.
- Demonstrate commitment to excellence and bring a high energy
level to daily activities as well as involve periods of high
intensity work under tight timelines.
- Works independently under supervision and collaborates with
- Trains others on procedures as appropriate.
- Bachelor's degree or equivalent in relevant discipline with a
minimum of 2 years' experience (4-7 years for senior
- Familiarity with eCTD structure for regulatory submissions is
- Outstanding verbal and writing communication skills, attention
to detail, strong planning, organizational and negotiating skills,
with focus on timely delivery.
- Proficiency in commonly used applications like Word/Excel is
required. Documentum experience is preferred.
- Experience with regulatory documentum software is required
along with proficiency in compliance ready standards for final
publication is a strong asset.
- Must be capable of working in a fast-paced changing team
environment, prioritizing multiple tasks to meet filing
- Possess strong interpersonal skills and demonstrate ability to
effectively interact with business functions.
This 6+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and
availability to Malika:
ALPHA'S REQUIREMENT #23-00766
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Keywords: Alpha Consulting Corp., Elizabeth , Documentation Analyst, Professions , Warren, New Jersey
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