Overview
MMS is an 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-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a high customer satisfaction rating and fosters a collaborative, inclusive work environment where employees can thrive. Join us at MMS and be part of a team shaping the future of clinical research.
Discover opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
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 maintains scientific integrity.
* Author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data.
* Develop a mapping plan for placement of nonclinical studies within the 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, biostatistics, regulatory operations, and CMC.
* Demonstrate the ability to lead others to complete complex projects.
* Complete documents according to sponsor formats, processes, and regulatory guidelines.
* Operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment.
* Establish yourself as an organizational expert within the nonclinical subject area.
* Exhibit excellent written and oral communication, and strong time and project management skills.
* Attend regular team meetings and client meetings; manage customer relationship management (CRM) activities.
* Work in client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates, and toolbars.
* Maintain a strong understanding of regulatory guidance as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines; GLP, GCP, GMP, GDP).
Requirements
* BS in pharmacology, toxicology, biology, chemistry, or related field, with industry experience in regulatory writing, regulatory affairs, laboratory sciences, or 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 trials and pharmaceutical development preferred.
* Basic understanding of CROs and scientific/nonclinical data terminology, and the drug development process.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Marketing, Public Relations, and Writing/Editing
Industries
* Pharmaceutical Manufacturing
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