1. Medical Writing
Medical Writing consultants shall be responsible for the preparation and submission of highquality regulatory and other supporting documents for NIH projects. The consultants shall coordinate with LDTs to prepare, edit, review, and submit documents to regulatory agencies (e.g., FDA) within project timelines. Documents may include but are not limited to clinical 4 protocols, Investigational New Drug applications (INDs), Investigator Brochures (IBs), IND Amendments, Drug Master Files, and Statement of Investigators (Form FDA 1572) and drug dossiers. The role of the Medical Writing consultant may include but is not limited to the following responsibilities and tasks: Work independently or as part of a team to gather, compile, write, and edit regulatory documents for submission to regulatory agencies. Ensure that submissions meet format and content requirements applicable to FDA requirements in compliance with ICH guidelines. Manage timelines for regulatory submissions. Work independently to complete assigned projects. Maintain familiarity with current best industry practices and regulatory requirements that affect medical writing. Review and perform quality control (QC) on other documents as part of the overall clinical research process.
2. Drug Dossier Development
Drug Dossier Development consultants shall be responsible for the preparation and submission of high-quality Drug Dossiers for EPPIC_net. The Consultants shall coordinate dossier development with the Asset holder. The role of the Drug Dossier development Consultant may include but is not limited to the following responsibilities and tasks: Work independently or as part of a team to gather, compile, write, and edit drug dossiers for submission to Asset Holder for onward submission to EPPIC-Net. Manage timelines for dossier submissions. Work independently to complete assigned projects. Maintain familiarity with current best industry practices and regulatory requirements that affect drug dossier development.
General requirements
Consultants must have extensive experience in managing or being a senior leader in drug discovery projects in the biopharmaceutical industry. Experience with drug discovery for nervous system conditions is preferred. • Broad experience across the entire drug discovery and development process is especially desired. • Consultants must demonstrate ability to educate and build trust with LDT members of many disciplines to build consensus and maintaining focus of team on milestone achievement. • Consultants must be able to work in a virtual, cross-functional team environment and manage competing priorities. 6 • Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy. • Consultants must have knowledge and understanding if global regulatory regulations and guidelines. • Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels. • Must participate actively in LDT discussions.
Job Types: Part-time, Contract
Pay: $60.00 – $75.00 per hour
Work Location: Remote
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