Senior Nonclinical Writer (US)

MMS•Canton Township, MI

1d•Remote

About The Position

This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position.

Requirements

BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control.
Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
5+ years of pharmaceutical regulatory nonclinical writing experience.
Strong writing and analytical skills.
Proficiency with MS Office applications.
Hands-on experience with clinical trial and pharmaceutical development preferred.
Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process.

Responsibilities

Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, 1st Edition Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs).
Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical submission documents for INDs/CTAs/NDAs/BLAs/MAAs, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity.
Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data.
Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents.
Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports).
Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC.
Demonstrated ability to lead others to complete complex projects.
Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines.
Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment.
Organizational expert within the nonclinical subject area.
Excellent written/oral communication and strong time and project management skills.
Ability to attend regular team meetings, lead client meeting and CRMs.
Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars.
Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP).