3-5 years of regulatory and clinical medical writing experience
Bachelor's, Master's, or Ph.D. in a relevant scientific or clinical discipline
Experience as lead author on clinical study protocols
Proven ability to lead and manage writing teams under tight deadlines
Understanding of clinical data synthesis
Proficient in MS Word, Excel, and PowerPoint
Responsibilities
Critically evaluate and interpret medical literature for study design
Write and edit various clinical development documents
Submit writing assignments on time
Manage writing timelines and workflow
Provide excellent customer service internally and externally
Ensure proficiency in regulatory writing styles
Be proactive in communication with clients for project coordination
Mentor other medical writers within project teams
Benefits
Support for continual training and skill development
Collaborative and team-oriented environment
Opportunity to positively impact lives through clinical trials
Global reach across four continents
High customer satisfaction rating
Full Job Description
Responsibilities
Under minimal 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, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
Complete writing assignments in a timely manner
Maintain timelines and workflow of writing assignments
Practice good internal and external customer service
Highly proficient with styles of writing for various regulatory documents
Expert proficiency with client templates & style guides
Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
Contribute substantially to, or manages, production of interpretive guides
Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
Mentor medical writers and other members of the project team who are involved in the writing process
Requirements
At least 3 years of previous experience in the pharmaceutical industry
Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
Substantial clinical study protocol experience, as lead author, required
Experience leading and managing teams while authoring regulatory documents with aggressive timelines
Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
Understanding of clinical 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
Experience being a project lead, or managing a project team
Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
Not required, but experience with orphan drug designations and PSP/PIPs a plus
