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
Veterinarian J669678
Unlock your potential with an exciting Associate Veterinarian role offering a salary of up to $150,000 plus a $30,000 sign-on bonus! The Hospital Join a full-service veterinary clinic that harmon…
Production Rework Technician III
Req ID 84461 | Marysville, United States ZF Axle Drives Marysville, LLC Position Summary: The incumbent will perform one of the following functions as their main responsibility: Safely per…
Plant Quality Engineer
Our client, a global leader in the design and manufacturing of electromechanical components for the automotive industry, is seeking a Plant Quality Manager to support plastic injection molding and as…
Facilities Manager (Maintenance) - Holiday Inn Express Grandville
The Holiday Inn Express Grandville is a fast-paced, high-energy workplace, with endless opportunities for advancement. Come join the best team in the Hospitality Industry! Facilites Manager: …
Advanced Skills Clinic Coach
Youth Basketball Coach Part-Time Non-Union Position STATEMENT OF THE JOB: Commonpoint seeks a dedicated Youth Basketball Coach to develop young athletes' skills, teamwork, and sportsmanshi…
CDL Class A Owner-Operator with truck
53' Dry Van Owner-Operator Hello, Logistix Services Inc. is HIRING Owner-Operators! Our MC# 1046151 Why Us? ~10% under our authority ~ No factoring fees ~ No forced dispatch ~ Affo…
Area Director 1 - Manistee, MI
If you are currently on Young Life staff, please do not apply through this external jobs board. To apply for internal job opportunities, log in to Workday and use the Jobs Hub . Applying externally…
Landscape Architect / Designer
Join our team at TowerPinkster and open a new door to an amazing career! TowerPinkster, an architecture, engineering, and interior design firm based in Michigan, Indiana, and Kentucky, is looking fo…
Oil Tech
Benzie Express Lube and Tire in Benzonia MI is under new ownership with K&R Tire. Join our drive-thru oil change team and be part of a growing business! We're seeking a motivated Oil Tech to help…
Custodian
Job Title: Custodian (Full-Time) Location: 28201 Van Dyke Ave, Warren, MI 48093 Pay Rate: $16.00/hour Schedule: Full-Time (Monday–Friday, shifts may vary) Job Summary: We are currentl…