Nonclinical Writer Job at MMS, Charleston, SC

UXRhMnYxL1UzaGVxUFhEMm9qbnV0V1h1R1E9PQ==
  • 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

Miso Robotics

Sr. DevOps Engineer Job at Miso Robotics

 ...restaurant brands. With a new leadership team, including a CEO with a track record of successful exits, and a strategic investment from Ecolab, Miso is poised for scale. The company is building a world-class team. We offer competitive compensation, accelerated growth... 

Encompass Health Rehabilitation Hospital of Harmarville

LPN / LVN Job at Encompass Health Rehabilitation Hospital of Harmarville

 ...Job Description LVN / LPN Career Opportunity Embark on Your Compassionate LPN/LVN Journey at Encompass Health Are you in search of a fulfilling healthcare career close to your heart and home? Encompass Health welcomes you warmly, offering a space that feels like... 

BayCare

Hospital Care Coordinator - RN Case Management Job at BayCare

 ...Position details: Location: St Anthony's Hospital - St Petersburg, FL Status: Part time, 16 hours per week Schedule: Saturday & Sunday, 8:00 AM - 4:30 PM Weekend Requirement: Every On Call: No Certifications and Licensures: Required RN (Registered... 

Gliacell Technologies

Junior DevOps Engineer Job at Gliacell Technologies

 ...currently do not possess this level of clearance.*** Are you a Junior DevOps Engineer who is ready for anew challengethat willlaunch your...  .... We Make It Happen! GliaCell Technologies focuses on Software & System Engineering in Enterprise and Cyber Security... 

Recora

Live Chat Support Agent Job at Recora

 ...Live Chat Support Agent Job Title: Live Chat Support Agent Classification: 1099 Work Structure: Fully Remote Shift: 10am-6pm ET Monday-Friday Team: Enrollment Operations Reports to: Product Manager Location: United States Compensation: $15-18 per...