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
OB/GYN Physician - Generalist
Optum NY, (formerly Optum Tri-State NY) is seeking a OB/GYN Generalist to join our team in Mount Kisco, NY. Optum is a clinician-led care organization that is changing the way clinicians work and liv…
Routing and Siting Specialist
Canacre's core services focus on leadership in Environment and Land services throughout the project lifecycle. At Canacre, we emphasize continuous development and growth. Our commitment to investing …
Assembly & Test Operator II
Job Title: Assembly & Test Operator II Location: Glendale, AZ Zip Code: 85307 Start Date: Right Away Pay Rate: $19.10/hr. Contract: 6 months Shift: 3rd Shift hours: 11pm-7am, Sunday night throug…
Vice President of Sales and Account Management - Small Business/Key Accounts - Phoenix, AZ
At UnitedHealthcare, we're simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of people fo…
Findlay GM Prescott - Sales Consultant
Findlay is one of the largest & fastest growing automotive groups in Southwest U.S. We're seeking top sales talent to help grow our business and keep up with the high demand. Our organization enjoys…
Travel Sonographer
HIRING NOW: Travel Sonographer in Yuma, AZ Weekly Gross Pay: $3,126 for 40 hours Taxable: $1,880 weekly ($47 x 40) Non-Taxable: $1,246 weekly ($31.15 x 40) Location: Yuma, AZ Shift: 8 h…
Senior Principal Software Development Engineer (IC5) - OCI
**Job Description** At Oracle Cloud Infrastructure (OCI), we build the future of the cloud for Enterprises as a diverse team of fellow creators and inventors. We act with the speed and attitude of a s…
Operations Assistant
Operations Assistant Legends Entertainment District / Chase Field Phoenix AZ Job Summary: Player 15 Group the sports & entertainment company behind the Phoenix Suns (NBA) Phoenix Merc…
Kitchen Manager - Bacio
Position Title: Kitchen Manager Expected Weekly Hours: 40 (off-season) – 50 (peak season) Overview Bacio Italiano is seeking a Kitchen Manager to oversee the daily operations of our back-o…
Content Creator (Model)
Want To Be Internet Famous? We’re Hiring Creators! Do you have enormous energy, big dreams, and tons of personality? Could you light up social media if just given the chance? Here’s your shot. …