Nonclinical Writer
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn . This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities:
- Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, 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 documents, 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)
- 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
- 2+ 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
Recommended Jobs
Facilities Manager
JLL empowers you to shape a brighter way. Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology fo…
Senior Embedded Vulnerability Researcher
Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise …
Sr. Quality Engineer (CQE required)
Our Opening and Your Responsibilities Our Senior Quality Engineer will lead the development and implementation of quality improvement initiatives aligned wi…
EVS Associate III
POSITION SUMMARY : The Project Technician will act independent of direct supervision providing superior service to the department's customers. The project technician will provide specialized se…
Perm - Radiologic Tech - X-Ray #A-MRT-62917
Summary: Ref #: A-MRT-62917 Profession: Allied Health Specialty: Radiologic Tech - X-Ray Job Type: Full-time Start Date: ASAP Location: Worcester, MA Shift Schedule: 8 hrs per day…
Delivery Driver - Day shift/Local route - Franklin, MA
Job Title: Delivery Driver Role Summary As a Delivery Driver, you play a critical role in delivering products to customers safely, accurately, and on time. You will operate a company vehicle…
Site District Manager I
The Resident District Manager is responsible for providing overall vision, planning, direction, and control to assigned units for a large and complex geographic district normally generating $20M+ in …
Home Weekly CDL-A Driver
We're actively hiring CDL-A drivers for one of the most rewarding and consistent routes in the trucking industry! This is a dedicated position where you'll be delivering dry freight. You will doliver…
Clinical Diabetes Specialist - Springfield, MA
About Beta Bionics Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing b…