Duties:
Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross-functional study and project teams. Manages all technical aspects of GMW document development as well as publishing and archiving activities and is the interface to Global Regulatory Operations. Accountable for Patient Narrative process and final delivery including coordinating the strategy, overseeing the process, managing timelines with cross-functional teams, and interfacing and overseeing the vendor to ensure timely and successful document finalisation. Responsible for the preparation of relevant content for global clinical documents (CTPs, IBs, CTRs, ICFs, or other relevant clinical documents) including the planning and set up in the document management system for authoring teams, the planning and strategy for document development, and the overseeing of timelines. Requires proactive and continuous cross-functional coordination with functional areas outside of GMW as well as external vendors or CROs to ensure timely and successful document finalisation. Manages and is accountable for all technical steps for document development. This may include the set-up, organization, and standard content management for various document types as well as overseeing and managing the publishing and archiving activities for global clinical documents managed by GMW. The Medical Technical Writer serves as the interface between GMW and Global Regulatory Operations. Ensures quality of the deliverables that are outsourced to vendors/CROs that are writing clinical trial reports or other clinical regulatory documents and acts as the interface to BI systems that are not accessible to external vendors. Develop in-depth knowledge in the technical writing area and stays on top of new developments and industry standards. Understand and utilize document formatting and writing conventions and standards. Exchange knowledge with Global Medical Writers and ensure new ideas are integrated and implemented within GMW. Please only subimt candidate is EST and enter their location in the submisison. Candidates sitting in CST or PST will be rejected.
Skills:
The job involves working in global, cross-functional study and project teams, coordinating, and supervising a time-sensitive technical process with cross-functional involvement. Additional complexity is introduced by external providers and awareness of cultural diversity. The job requires handling numerous complex tasks simultaneously. Sound knowledge of document management systems, clinical documents standards, clinical trials, their documentation, and regulatory requirements. Deep knowledge of international writing standards and conventions and regulatory writing. Sound knowledge of safety reporting and regulatory requirements. Ability to proactively identify problems and initiate improvements. Understanding of the business impact of timelines for clinical documents. Excellent written and verbal English skills, sound knowledge of MS Office (especially Word, Adobe), Microsoft 365, document management systems, and high IT affinity. Places a high priority on regulatory compliance and quality. Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers. Ability to manage parallel tasks and variable workload. Strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, cultural sensitivity. Education:
Master's degree with a minimum of 2-3 years or a bachelor's degree with a minimum of 3-5 years of working experience, preferably in e.g. natural sciences, pharmacy, medicine or digital technologies, project management or communication science or any other relevant field with at least 3 years of professional experience preferably in clinical operations or related areas; alternatively vocational training, associate's degree, technical college e.g. in medical documentation or other relevant fields, with at least 5-8 years of professional experience and preferably 3 years of experience in technical writing, clinical operations or related areas.
Pay Rate Range: $40-58/hr. Salary will be commensurate with experience
