Nonclinical Writer Job at MMS, Charleston, SC

VUxOSnFkK0tYU1h3RnBaMXBEUEJOVUVYekE9PQ==
  • MMS
  • Charleston, SC

Job Description

Job Description

Job Description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

 
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)
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
  • 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

Powered by JazzHR

6HpfnV20bH

Job Tags

Full time, Remote work,

Similar Jobs

CompHealth

Locum | Physician Emergency Medicine Job at CompHealth

CompHealth services are always free to you. Let us do the heavy lifting and handle the headache of credentialing, travel, housing, and so much more. With the premier staffing agency as your champion, you can achieve more success with less worry. No other agency has our ...

Prep Academy Tutors

Reading and Math: Elementary teachers needed Job at Prep Academy Tutors

 ...students. We specialize in all subject areas and cater to students from kindergarten to grade 12. We hire only the BEST - certified teachers, or those in the process of completing their degree in Education and pay higher wages than the industry average. Job Summary... 

Outlaw Trucking Group

Owner Ops Needed Power Only Loads Book Your on Loads CDL Driver Job at Outlaw Trucking Group

 ...Need owner operators for small company Your authority or ours is ok Must have tags to be in our program ~ SAP drivers ok owner ops only You choose and book your own loads Must run 1 week of loads at a time After that take as much home time as... 

G&W Electric

Electrical Tester I Job at G&W Electric

G&W Electric is seeking a dedicated Electrical Tester I to join our Technical & Maintenance department. As a hallmark of quality and reliability in electrical solutions for over a century, G&W Electric focuses on enhancing power grid performance through advanced technology... 

Primark

Assistant Store Manager Job at Primark

Job Description Because every day is an opportunity! Do Retail our Way. At Primark were caring, dynamic and we succeed together. We have amazing fashion at amazing prices, all the time. We set the fashion trends. Were committed to providing our customers with service...