Remote Medical writing Jobs • Medical Writing

Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents.

Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. Exhibits excellent written and oral communication and presentation skills.

As a Sr. Medical Writer, you will develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles. You will actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents. Assist in working practices to allow the effective and efficient preparation of quality documents.

You will be joining the world’s largest & most comprehensive clinical research organisation. As a Senior Medical Writer you will be supporting a Top-5 pharma company and help deliver best-in-class regulatory and submission documents while being stably employed with ICON. Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers across multiple therapeutic areas.

Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents, reviews statistical analysis plans and interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.

This role will help to shape the tactical execution of our client’s programs and offer unique solutions to challenges while contributing to tactical recommendations that align with either medical or commercial strategic imperatives and overall client business objectives. Responsibilities include medical writing activities for multiple projects and to ensure high-quality execution.

The primary responsibility is to ensure that all content developed is evidence-based, is of the highest editorial quality, meets the strategic objectives of our clients, and ultimately, translates science into clinical benefit across medical education, communications, brand, and training. They may develop content as well as serve as the primary quality-control contact for internal and external content development.

The Director, Strategic Medical Writing directs centralized clinical writing function across therapeutic areas and/or multiple drug programs within Development, ensuring successful preparation of high quality, submission-ready documents and effective management of the clinical writing process in accordance with clinical and regulatory timelines. Oversees business systems that support clinical regulatory document creation.