Senior Specialist

Nonclinical Writing and Documentation Management

Posted on 10/11/2023

INACTIVE

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

IPO

Total Funding

$1.4B

Founded

2018

Headquarters

Cambridge, Massachusetts

Growth & Insights

Headcount

6 month growth

↑ 5%

1 year growth

↑ 12%

2 year growth

↑ 91%

Locations

Remote in USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

Communications

Word/Pages/Docs

CategoriesNew

Content & Writing

Requirements

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

Responsibilities

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

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 Manager of Nonclinical Writing and Document Management, we are seeking an experienced, motivated, and highly organized individual to assist with the management of nonclinical document-related activities across the Cerevel portfolio. Your responsibilities include leading the nonclinical writing activities as required for early development programs, supporting the nonclinical writing efforts for regulatory submissions, and supporting the Research Organization to create in-house study reports, with the potential opportunity to independently manage additional nonclinical writing activities for future programs. Occasional travel to Cerevel’s Cambridge office is required. You will be expected to successfully work independently with minimal supervisory input, cooperatively, and efficiently within a fast-paced environment with multiple timelines. This position will also provide opportunities to learn more about, and directly contribute to, the drug development process as we bring these much-needed therapies to patients.

Key Responsibilities

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

Required Qualifications

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

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

Education

B.S. / M.S. or equivalent in biology, biochemistry, toxicology, 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.