The Medical Writer participates as a member of the Product Development Team (PDT) and serves as team specialist in matters pertaining to study and regulatory documentation. The Medical Writer will prepare, edit, and review clinical and scientific documents such as study protocols and clinical study reports, Investigator's Brochures, and documents for pre-IND meetings and IND applications according to requirements and regulations. The Medical Writer will also assist in the preparation of statistical and safety analyses, manuscripts, abstracts, posters, and review articles, as needed. The Medical Writer will also be expected to review and edit documents for organization, clarity, use of English language/grammar, and scientific standards; resolve errors and inconsistencies in data with the Project Manager, Team Leader and other PDT members, as necessary. The candidate will be an experienced Medical Writer in the biotech/pharmaceutical industry with a proven track record of successful publication.
- Development and editing of study protocols, study reports, manuscripts, corporate documents, product development plans, investigator brochures, grant applications and regulatory documents;
- planning content, format and timing of documents;
- supporting the PDT to ensure that project needs are effectively met;
- supporting and contributing to the company's publication strategy;
- interacting with project physicians, statisticians, regulatory personnel and facilitating
- effective interactions and information exchange/communication among coauthors and reviewers as appropriate;
- attending meetings and teleconferences with reviewers to understand and resolve comments and issues;
- assembling periodic status reports and presentations for management.
- direct experience with drafting and finalizing study reports, manuscripts and medical/scientific publications;
- exceptional writing skills with the ability to communicate in a clear and concise form, clear, high quality scientific writing style in the English language;
- solid understanding of ICH guidelines and strong written and verbal communication skills;
- organized, detail oriented and have the ability to successfully manage multiple projects from conception to completion;
- self-starter and must function well under minimal supervision;
- advanced degree preferred or strong demonstration of equivalent combination of relevant educational and professional training;
- three (3) years of experience in a Pharmaceutical/Drug Discovery Medical Writing role;
- proficiency in Microsoft Word, Excel and PowerPoint and in addition to Adobe Acrobat.
Job Types: Full-time, Contract
- Master's Degree (Preferred)
- English (Required)