Manager – Technical Operations Document Management
Updated on 4/5/2024
Cerevel Therapeutics

201-500 employees

Develops therapies for central nervous system disorders
Company Overview
Cerevel Therapeutics stands out as a leading biopharmaceutical company with a concentrated focus on developing therapies for central nervous system disorders, a field that impacts hundreds of millions globally. Their competitive edge lies in their robust portfolio of experimental neuroscience therapies, including three clinical-stage compounds and several pre-clinical compounds, targeting a wide range of disorders such as Parkinson’s, Alzheimer’s, and epilepsy. The company's culture is driven by a commitment to understanding neurocircuitry deficits, which fuels their research and development efforts towards addressing these underserved areas and communities.
Biotechnology

Company Stage

N/A

Total Funding

$1.8B

Founded

2018

Headquarters

Cambridge, Massachusetts

Growth & Insights
Headcount

6 month growth

7%

1 year growth

15%

2 year growth

57%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Management
CategoriesNew
Operations & Logistics
Quality Control & Compliance
Requirements
  • Minimum of 7-10 years of relevant document control experience in the biotechnology or pharmaceutical industry or in a manufacturing setting
  • Hands-on experience with vQV or equivalent electronic document management system
  • Prior authoring of eCTD Module 3 sections supporting regulatory submissions
  • Relevant industry experience in CMC-related scientific writing, QC activities and processes in a regulated (GMP-compliant) environment including batch production records, manufacturing procedures
  • High attention to detail and aptitude for change agility; successful management of multiple concurrent activities
  • Excellent communication (both oral and written), facilitation, and interpersonal skills with demonstrated ability to manage timelines and generate quality work while using these skills in a cross-functional team setting
  • Exercise good judgement in elevating and communication issues to line management; contribute to problem solving and resolution
  • Thrives in a dynamic, fast-paced environment with the capacity to successfully complete tasks independently in a remote start-up environment
  • Acts with integrity and respect always
Responsibilities
  • Manage controlled documents in Veeva Vault Quality Docs (vQD) for programs: drafting documents, maintaining metadata, linking supporting documents, maintaining revision control as needed
  • Support generation, review, and submission of eCTD Module 3 documents
  • Serve as group liaison/representative with key functional groups (eg, Global Product Quality)
  • Conduct detailed document reviews to ensure accuracy and completeness, including quality control (QC) reviews against source documents
  • Identify and support process improvement initiatives
  • Ability to build relationships and work collaboratively with Tech Ops subject matter experts to actively track and confirm deliverables to ensure timely generation of high-quality documents