Manager, Document Management

Remote
Research and Technical Operations – Technical Operations /
Full Time /
Remote
Company Overview

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.  
 
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.
 
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.  Our patient-centricity guides our purpose, how we treat each other and what we work on every day.  The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

Reporting to the Senior Director of Safety Assessment, we are seeking an experienced, motivated, and highly organized individual with an outstanding attention to detail to assist with the management of document-related activities supporting Technical Operations (Tech Ops). Your key responsibilities include developing and administering best processes and practices for document oversight and documentation compliance across Cerevel’s portfolio.  Additional responsibilities include cross-functional interactions supporting accurate and timely health authority/regulatory submissions across Cerevel’s portfolio. Occasional travel to the Cerevel office may be required for business needs.  You will be expected to work independently with minimal supervision, cooperatively, and efficiently within a fast-paced environment with multiple timelines. This position will also provide you with opportunities to learn more about and directly contribute to the drug development process as we bring these much-needed therapies to patients.

Key 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

Required Qualifications

    • 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

Desired Quaifications

    • Strong scientific background in analytical and/or pharmaceutical sciences preferred
    • Prior group or team management experience
    • Proficient in the use of Veeva Systems, Microsoft Office products (Word, Excel), Adobe Acrobat, SmartSheet, and creating/utilizing structured document templates
    • Working knowledge of regulatory guidances and eCTD requirements for NDAs, INDs, CTAs, IMPDs, etc.

Education

    • B.S. / M.S. or equivalent in analytical or pharmaceutical sciences or other scientific discipline
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law