Medical WriterApply Now
Location: Cambridge, Massachusetts 02142
Employment Type: Contract
Job Summary: Creative, resourceful, integrative thinker for a contract role that is responsible for planning and preparing clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations.
- Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines in order to support drug development under strict timelines.
- Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient production and publishing of documents and dossiers.
- Function as an integral part of the Medical Writing team which includes external vendors.
- Ensure a consistent style of presentation of documents to maintain quality and ease of review.
- Perform quality control (QC) review of clinical study reports and other submissions written by other medical writers.
- 3+ years as a medical writer and presenting relevant specialist qualifications;
- Bachelor’s degree in a clinical, scientific, or industry-related discipline
- Working knowledge of ICH and US regulatory requirements is required
- Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
- Familiarity with the requirements for preparation of key clinical and regulatory documents
- Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system
Brian is responsible for uncovering the right candidates and managing them through the interview and hiring process.
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