.As a Principal Medical Writer, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.As a principal medical writer, you will be supporting a Top-5 biotech company.You have the chance to help our customer deliver best-in-class regulatory and submission documents.While being stably employed with ICON, you will be fully embedded with our client.Your excellence in medical writing will help them reduce time to market of their deep antibody pipeline.The position is home-office based.Your contribution will be in the challenging field of autoimmune diseases.While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.What You Will Be Doing Medical Writing Excellence: You will deliver all types of clinical, regulatory, and submission documents.
You will draft and manage documents that are superbly organized, accurate, consistent, unambiguous, and written for the target audience.
Key documents to develop will include clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules, and other clinical and regulatory documents.
You will take up a lead role in advising and guiding clinical teams on content and processes.
You will ensure that all applicable company SOPs and regulations are upheld.
Lead in a multi-shareholder environment to ensure seamless delivery of best-in-industry regulatory documents.
Closely interact with clinical program leadership and clinical teams to set up and safeguard challenging project deadlines.Functional Leadership: You will be a pivotal member of clinical teams in pro-actively guiding them on best-in-class medical writing processes.
You will drive consistency of documentation using document templates and company style guides across programs.
Ensure dissemination of industry and health-authority regulatory guidelines.
Represent the medical writing function at internal meetings (e.G., project and program management status updates).
You will proactively provide recommendations for potential process improvements to foster best-in-industry delivery of regulatory documents of the highest quality.
You may represent the Medical Writing department in industry standards working groups.
Represent the medical writing function during an audit of clinical trial documents to guarantee timely response to findings.You Are Minimum of 6 years of pharmaceutical/biotechnology-related medical writing required.
Master's degree in a scientific, medical, or clinical discipline or related field required; PhD preferred.
Can interpret and implement all FDA and ICH guidelines for clinical reporting.
eCTD development and submission experience preferred.
Pivotal understanding of key phases, processes, and techniques of drug development from protocol development through submission