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Nonclinical Medical Writer

at MMS Holdings Inc. in Newark, Delaware, United States

Job Description

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn (https://www.linkedin.com/company/mms-holdings-inc-/) .

Will participate in the development, writing, and management of Nonclinical-related documents.

Roles and Responsibilities:

+ Strong experience with development and writing of Nonclinical-related documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents)

+ Lead projects independently with minimal oversight

+ Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data

+ Collaborate with cross-functional teams such as safety, biostats, CMC, and clinical

+ 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

+ Strong understanding of regulatory guidances as it applies to nonclinical submissions (eg, NDAs, MAAs, INDs, IMPDs)

+ Strong understanding of pharmacokinetics as it applies to nonclinical reports and nonclinical submission modules

Requirements:

+ BS + in biology or chemistry, or related field, with industry experience within regulatory affairs, laboratory sciences, quality assurance/control

+ Knowledge of GMP, ICH guidelines, and applicable regulatory requirements

+ 2+ years of pharmaceutical regulatory Nonclinical writing experience

+ Strong writing and analytical skills

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Job Posting: JC143531965

Posted On: Jun 24, 2019

Updated On: Nov 12, 2021