Senior Drug Safety Writer

Job title: Senior Drug Safety Writer

Company: MMSH Clinical Research Pvt Ltd



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 www.mmsholdings.com 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

Requirements

  • Experience in aggregate reports (DSURs, PBRER/PSUR) and RMPs
  • 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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Other details

Expected salary:

Location: Mumbai, Maharashtra

Job date: Sun, 09 May 2021 07:24:22 GMT

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