Medical Writer – Work From Home

Job Type: Medical Writer from home
Location: California work from home
Company: Inventing for life

Position Description:

The Principal Medical Writer is capable of working independently to accomplish objectives and is responsible for the development and management of medical writing deliverables that support the clinical regulatory writing portfolio.

In this capacity, the Principal Medical Writer:

• Has earned a reputation as a prominent scientific contributor and subject-matter specialist in the creation of regulatory clinical documentation.
• To support pipeline initiatives, one applies in-depth understanding of regulatory medical writing, therapeutic area, and investigational product. a cross-functional team member who represents a functional area (either internally or externally).
• produces expectations-conforming, high-quality paperwork on schedule. uses own judgment, previous job experience, and a comprehensive understanding of the impact on other disciplines to interpret and apply knowledge of regulatory, compliance, and scientific requirements.
• Leads and oversees medical writing tasks, such as the creation of clinical documentation for trials, clinical development, and submissions (such as pivotal CSRs) (e.g., clinical modules). To get results, collaborates with coworkers from different functional areas.
• solves complex challenges related to the scope of work for medical writing, including unclear scenarios involving different departments and the necessity to come up with fresh solutions.
• oversees the work of other medical writers, offering guidance and coaching in the development, organization, and completion of their projects on a scientific and practical level. comments to their bosses on performance evaluations and development goals.
• leads programs, standards, and methods for medical writing.

Education minimum necessary:

• the Life Sciences degree.
• Bachelor’s degree with 10+ years, MS with 8+ years, or PhD with 5+ years of relevant professional experience

Required education and training:

• five to ten years’ experience writing regulated documentation for the pharmaceutical and/or biotech industries. Possess the skills necessary to independently prepare any type of clinical regulatory document (such as a protocol, CSR, CIB, or the clinical sections of an IMPD or CTD) in accordance with company policies and international legal requirements. You should also be able to present clinical data objectively and in a manner that adheres to industry standards.
• Assume management and leadership responsibilities for teams of medical writers working on difficult documentation projects.
• Knowledge of SharePoint and the principles of organized content management, as well as technical proficiency in Microsoft Office, Adobe Acrobat, document management systems, and these other areas.
• Excellent project management and communication skills, especially presentation skills. being aware of demands outside clinical development in the pharmaceutical sector.