Job Title: Medical Technical Writer

Location: Remote from EST Time Zone Only.

Type: 2 year contract

Responsibilities

• 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 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 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.

• 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 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.

  Requirements

• 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.

• Project Management

• Regulatory Compliance

• Adobe Acrobat

• Document Management Systems

• Medical Writing

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.