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MMS Holdings Inc. Medical 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-/) .

We are looking for candidates with at least 2 years of industry/ pharma or postdoctoral experience to join our team. We offer competitive pay and a full benefits package. Remote positions are not available for this specific role, so anyone outside of MI would need to be open to relocation.

Job Description

  • Under initial supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias

  • Write and edit clinical development documents, including but not limited to, clinical protocols, investigator?s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials and publications to medical journals, with initial guidance

  • Complete writing assignments in a timely manner and have the ability to be flexible with changes in scope or timelines

  • Maintain timelines and workflow of writing assignments

  • Practice good internal and external customer service

  • Proficient with styles of writing

  • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects

  • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary

Requirements

  • Must have at least 2 years of industry/ pharma or postdoctoral experience

  • The ideal candidate would hold a Ph.D. in scientific, medical, clinical discipline

  • Understanding of scientific data

  • Exceptional writing skills are a must

  • Excellent organizational skills and the ability to multi-task are essential prerequisites

  • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools

  • Regulatory writing experience and expert proficiency with client templates & style guides a plus

  • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus

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