Medical Writer II Job Description
We are seeking a Medical Writer to play a pivotal role in the development and preparation of clinical trial documents, regulatory submissions, and scientific publications.
* Key Responsibilities:
* Collaborate with cross-functional teams to prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents.
* Conduct literature reviews, data analysis, and interpretation of clinical trial results to support the development of scientific manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and scientific conferences.
* Assist in the review and validation of clinical data, ensuring accuracy, completeness, and consistency with study protocols, standard operating procedures (SOPs), and regulatory requirements.
* Participate in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables.
Required Skills and Qualifications
* Proficiency in scientific and medical terminology, with excellent written and verbal communication skills.
* Strong analytical and critical thinking skills, with the ability to review and interpret clinical data.
* Familiarity with regulatory requirements, industry guidelines, and publication standards governing the preparation and submission of clinical trial documents and scientific manuscripts.
What You Will Gain
This role offers an exciting opportunity to contribute to the advancement of innovative treatments and therapies. As a Medical Writer, you will have the chance to work on complex projects, develop your skills, and make a meaningful impact in the field of clinical development.