Senior/ Principal Regulatory Medical Writer - Connect Life Sciences
Canton, MI 48187
About the Job
Connect Life Sciences is partnered with a Clinical Research organization that has multiple openings for Regulatory Medical Writers.
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 3 years of industry/ pharma or postdoctoral experience
The ideal candidate would hold a Masters or 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
Employment Type: Full-Time
Salary: $ 110,000.00 160,000.00 Per Year
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 3 years of industry/ pharma or postdoctoral experience
The ideal candidate would hold a Masters or 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
Employment Type: Full-Time
Salary: $ 110,000.00 160,000.00 Per Year
Source : Connect Life Sciences