This new team member is capable of the creation and amending, any type of clinical regulatory document (e.g., protocol, CSR, IB, clinical sections of IMPD, PIPs, IND Amendments and CTD Granular Documents such as Module 2, ISS and ISE, etc.) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format.
This person is independent, proactive, experienced medical writer with demonstrated leadership preparing multiple key summary submission documents on time while interacting with multiple individuals/teams in a fast-paced environment. This person; has excellent communication skills and strong interpersonal skills.
The successful candidate will support the clinical team and the regulatory team and will report into the clinical department.
• As an integral part of clinical and regulatory study teams, the position ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical-RA documents using advanced word processing. • This person must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers. • This person will manage completion of high-quality documents on time and ensure that other contributors meet writing deadlines. • This person must work with project teams to prepare clinical regulatory documents, including protocols, study reports, investigator brochures, PIPs, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development under strict timelines. • This person must provide leadership in completing major summary submission documents (e.g., pivotal study reports, Clinical Summary of Efficacy, Clinical Summary of Safety, Clinical Overview) to support high-quality submission dossiers. • This person will create a style guide and ensure a consistent style of presentation of clinical document to maintain quality and ease of review. • This person must work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers. • This person will contribute to Project Teams, and Submission Task Force meetings and cross-functional working groups as needed to facilitate efficient development and submission of products. • This person may mentor more junior medical writers and/or manage external consultants to provide leadership in completion of large writing projects.
• Bachelor’s degree and advance degree in life sciences required including more than five years’ experience in writing, or equivalent related to the Biotech-Pharmaceutical Industry and drug development. Must provide Writing Sample (non-confidential). • Strong understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology. • Excellent command of the English language in both spoken and written forms. • Accurate and detail-oriented with excellent inter-personal skills. • Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. • Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment. • Demonstrated leadership, problem-solving ability, sense of urgency, and ability to prioritize tasks across multiple projects. • Demonstrated ability to complete high-quality documents according to tight timelines. • Specific knowledge of oncology and clinical development in oncology is strongly desirable, as is submission experience with biological product.
• The successful candidate will have the unique opportunity to work and gain experience in an international company with a dynamic, and collegial environment. • The successful candidate will be given interesting tasks with opportunities for personal initiative and professional growth. • The compensation and benefits will be commensurate with experience.