Senior Specialist
Nonclinical Writing and Documentation Management
Posted on 10/11/2023
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.

Company Stage


Total Funding





Cambridge, Massachusetts

Growth & Insights

6 month growth


1 year growth


2 year growth

Remote in USA
Experience Level
Desired Skills
Content & Writing
  • Minimum 5 years of relevant scientific writing experience in the CRO, biotechnology/pharmaceutical industry, or other scientific field
  • High attention to detail with the ability to maintain an understanding of the overall project
  • Aptitude for change agility and 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 in a cross-functional team setting to complete projects
  • Ability to verbalize issues, contribute to problem solving and resolution
  • Familiarity with scientific research concepts, practices and generating reports to accurately capture study designs, resulting data, and overall study conclusions and outcomes
  • Proficient in the use of Microsoft Office products (Word, Excel), Adobe Acrobat, and creating and utilizing structured document templates
  • Thrives in a dynamic, fast-paced environment with the capacity to successfully complete tasks with moderate supervision in a remote start-up environment
  • Acts with integrity and respect always
  • B.S. / M.S. or equivalent in biology, biochemistry, toxicology, or other scientific discipline
  • Assume responsibility as a primary nonclinical scientific writer and assist with coordination for IND and related submissions, routine annual IND maintenance activities (IB, DSUR), other regulatory document updates, and internal research reports
  • Assist with oversight and management of external consultants and vendors
  • Ability to build relationships and work collaboratively with internal scientists, external consultants, Contract Research Organizations, Medical Writing, and Regulatory Operations to actively track deliverables to ensure on-time generation of high-quality submission documents
  • Perform QC reviews of nonclinical submission documents
  • Ensure internal and external adherence to Cerevel writing style guides, templates, and procedures for nonclinical document development
  • Participation in or management of document review processes including comment/edit integration and resolution
  • Assist with generation of internal departmental SOPs, document templates, and best-practice documents based on current processes or process improvement initiatives
Desired Qualifications
  • Strong scientific background in nonclinical science preferred
  • Direct experience authoring nonclinical documents, study reports, or regulatory submission documents or relevant industry experience in scientific writing, quality control activities and processes in a regulated (GLP-compliant) and/or non-regulated (research) environment
  • Experience with formatting Microsoft Word and Adobe Acrobat documents to submission-ready standards
  • Working knowledge of regulatory guidances and eCTD requirements for NDAs and INDs (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator's Brochure, DSURs)
  • Understanding of FDA regulations, ICH guidelines, Good Laboratory Practice Regulations