Specialist II, Technical Operations Document Management

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.

 

Reporting to the Manager of Technical Operations Document Management, 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 primarily for Technical Operations and other groups as needed. Your key responsibilities include supporting best processes and practices for documentation compliance, Document Management, and supporting accurate and timely health authority/regulatory submissions across Cerevel's portfolio. Additional responsibilities will include updating procedural-related documents, supporting document archiving activities, project management tasks, and testing of new functionality within the Document Management system. You will be expected to work independently with moderate supervisory input, 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 (VVQD): drafting documents, maintaining metadata, linking supporting documents
• Assist with maintaining revision control for all controlled documents within TechOps, and other departments as needed
• Conduct detailed draft document reviews to ensure accuracy and completeness
• Identify and support process improvement initiatives
• Support submission of eCTD Module 3 documents
• Conduct quality control (QC) reviews against source documents
• Ability to build relationships and work collaboratively with different subject matter experts to actively track and confirm deliverables, ensuring timely generation of high- quality documents

Required Qualifications

• Minimum of 3 years of relevant document control experience in the biotechnology or pharmaceutical industry or in a manufacturing setting
• High attention to detail with the ability to maintain an understanding of the overall task at hand
• Hands-on experience with document revisions and/or Document Management including batch production records, manufacturing procedures, and cross functional procedures
• 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
• Exercising good judgement while independently identifying issues and resolving problems
• Familiarity with or direct experience working with regulatory guidelines or in a cGMP- regulated environment
• Proficient in the use of Veeva Systems, Microsoft Office products (Word, Excel), Adobe Acrobat, and creating/utilizing structured document templates
• 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 Qualifications

• Strong scientific background in analytical and/or pharmaceutical sciences preferred
• Functioned as an author or reviewer for CMC-related documents, reports, or regulatory submission (eCTD Module 3) documents, or relevant industry experience in scientific writing, QC activities and processes in a regulated (GMP-compliant) and/or non- regulated (research) environment
• Working knowledge of regulatory guidances and eCTD requirements for NDAs, INDs, CTAs, IMPDs, etc.
• Smartsheet, PowerBI and Power Automate skills a plus

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 .