3-5 years of industry regulatory and clinical medical writing experience
Bachelor's, Master's, or Ph.D. in scientific or medical disciplines
Proven experience as lead author on clinical study protocols
Capability to lead and manage teams under tight deadlines
Strong understanding of federal and ICH regulations
Exceptional writing and organizational skills
Proficiency in MS Word, Excel, and PowerPoint
Responsibilities
Evaluate and interpret medical literature for study design
Write a variety of clinical documents and publications
Complete writing tasks on time while managing workflow
Ensure high-quality customer service internally and externally
Maintain mastery of regulatory document styles
Collaborate with clients directly to manage projects
Mentor medical writers and project team members
Benefits
Opportunity for professional growth and development
Collaborative and diverse work environment
Engagement in cutting-edge research
Supportive organizational culture that values teamwork
Ability to work with a global footprint across multiple continents
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
