Narrative Writer

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Hlx are partnered with an award-winning, data-driven CRO that specialises in supporting the pharmaceutical and biotech industries with complex clinical trial data and regulatory submission challenges. They’re currently looking for an experienced Narrative/Safety Writer to join their team for some exciting upcoming projects.

Job Specific Skills

• Maintains an extensive understanding of regulations and guidance as they pertain to safety writing; mentors others and provides updates on related regulatory updates.
• Understands styles of writing for various document types, including more complex document types; mentors others; document SME.
• Proficient with QC process, MW/Safety writing tools and provides mentorship to others.
• Proficient with templates, toolbars, and formatting.
• Proficient with client processes and training; 100% compliant.
• Proficient in understanding impact of updates in related deliverables.
• Independently managing/leading client meetings and CRMs for effective resolutions.
• Proficient with managing a project from start to finish and compliant with process; identifies efficiencies within dept processes.
• Proficient with identifying and mitigating project risk, including assessing client gaps.
• Proficient with handling client feedback with appropriate feedback.

Requirements

• College graduate in scientific, medical, clinical discipline or related field, or related experience, masters or PhD preferred.
• Minimum of 3 years’ experience in Safety Writing or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organisational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Writing/Editing, Consulting, and Science

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Research Services