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MMS Holdings Inc. Senior Drug Safety Writer in Canton, Michigan

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 www.mmsholdings.com or follow MMS on LinkedIn (https://www.linkedin.com/company/mms-holdings-inc-/) .

Job Description

  • 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

Requirements

  • 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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