Senior Drug Safety Writer

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

Job Description

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience 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 was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit or follow MMS on LinkedIn ( .

Roles and Responsibilities

+ Responsible for writing safety documents intended for submission to regulatory agencies.

+ Responsible for writing patient CSR narratives and producing high quality documents

+ Practices excellent internal and external customer service

+ Good understanding of MS Word for advanced writing techniques

+ Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client

+ Ensure documents comply with appropriate ICH and regulatory guidelines

+ Interact directly and independently with client

+ Ability to follow MMS and sponsor processes

+ Practices internal and external leadership skills


+ College graduate in scientific, medical, clinical discipline or related field, or related experience

+ Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing

+ Master’s or PhD in a scientific, medical, or clinical discipline preferred

+ 1-3 years’ experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment

+ Understands ICH guidelines, as applicable to medical writing for clinical studies

+ Excellent written English skills

+ High degree of organization and able to manage multiple projects at any given time

+ Attention to detail and committed to excellence in all aspects of their work

+ Excellent communication and interpersonal skills

+ Proficient in Microsoft Word and Adobe Acrobat

+ Experience in the use of an Electronic Document Management system

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Job Posting: JC139751672

Posted On: Apr 12, 2019

Updated On: Jul 01, 2022