Senior/ Principal Regulatory Medical Writer Job at Connect Life Sciences, Canton, MI

VFhPNkxaSWRObU5iSStGTGpuOVdpdFczOHc9PQ==
  • Connect Life Sciences
  • Canton, MI

Job Description

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 Tags

Full time, Flexible hours,

Similar Jobs

No Leash Needed

Dog Boarding and Daycare Attendant Job at No Leash Needed

 ...service-related industry and you should not only be skilled at customer service, but passionate about helping people. Youll work in our Daycare and Boarding areas to care and ensure the safety of the guests in our facility. Not only will you focus on handling dogs all day,... 

Jet Linx

ATP Flight School - Pathway Job at Jet Linx

 ...values as they prepare for the next stage in their career. Minimum Qualifications to be Considered: Must be an active, recommended CFI at ATP Flight School. Must meet minimum hour requirements approved by ARGUS Must be willing to commit minimum of 3 years to Jet... 

Domino's Franchise

Delivery Driver - 2600 Bridge Avenue Job at Domino's Franchise

 ...Job Description Delivery Drivers are responsible for delivering food to customers with excellent customer service and a positive attitude. Why deliver for us: Great pay - Our drivers receive a competitive hourly wage, plus tips Benefits - All team members... 

Ginas Tech Jobs

Data Transfer Officer, TS/SCI with Full Scope Poly Security Clearance Required Job at Ginas Tech Jobs

 ...Data Transfer Officer, TS/SCI with Full Scope Poly Security Clearance Required, Herndon, VA Ready to hire a Data Transfer Officer. Qualified candidates must have an active TS/SCI with Full Scope Poly Security Clearance. Military (Air Force, Army, Navy, Marines) experience... 

Blue Horizons Development

Promotions Assistant: Marketing. Advertising. Public Relations Job at Blue Horizons Development

 ...We are a leading marketing and event promotions firm committed to crafting engaging and effective campaigns that connect brands with their target audiences. Our team is dedicated to delivering innovative marketing solutions and impactful public relations strategies. We...