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About the role
Key responsibilities & impact- 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, Informed Consent Forms and Clinical Protocols
- 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 communication 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
What you’ll need- 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
- Oncology, General Medicines, Infectious Diseases and Vaccine experience preferred
- Substantial informed consent and clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Experienced in understanding complex clinical information
- Translate complex medical and scientific information into clear, patient-friendly, language
- Experienced in collaboration and cross-functional communication
- 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
Benefits
Comp & perks- Enthusiasm, collaboration, and teamwork are fostered
- Continuation training to strengthen core skills
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory writingclinical medical writinginformed consentclinical study protocolproject managementclinical information analysisscientific writingpatient-friendly communicationGood Clinical PracticesICH guidelines
Soft Skills
communication skillsorganizational skillsmulti-taskingmentoringcustomer serviceteam leadershipcollaborationproactive consultationtimely completioninterpretation of medical literature