2 year Fully Remote contract position, East Coast Only, working for an Industry leader globally recognized pharmaceutical company with a strong reputation for innovation and cutting-edge research in the healthcare industry.
Job Detail
Job Description
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 finalization.
- 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 finalization.
- 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.
- 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 stay 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.
Qualifications:
- Master's degree with a minimum of 2-3 years or a bachelor's degree
- 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
- 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
- At least 5-8 years of professional experience and preferably 3 years of experience in technical writing, clinical operations or related areas
- Project Management, Regulatory Compliance
- Adobe Acrobat, Document Management Systems, & MS Office
Required skills
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This is a hybrid position, offering the flexibility to work remotely with the requirement to visit the office in New Providence, NJ bi-monthly, specifically on alternate Wednesdays.