Job Information
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