Job Description

At Roche , we advance science so that we all have more time with the people we love. Your Opportunity To author and produce regulatory documents for submission to regulatory authorities. Includes authoring complex CMC sections of BLA, pre-meeting packages, and other regulatory documents. Working with guidance, the Assistant Technical Writer takes accountability for timely delivery of clear and concise regulatory documents, working effectively and closely with content owners, and applying regulatory standards such as the use of Model Documents and Storyboards. The Assistant Technical Writer applies scientific writing, document, and project management expertise and contributes to the functional excellence of regulatory documentation through process management, and identification of systems or tools to streamline content transfer from the originating functions into final submissions. Responsibilities: Manages the preparation of a suite of regulatory documents with senior team members. Works with content owners and project teams to ensure that key information is clearly described. Creates and tracks timelines for the production of assigned documents in alignment with regulatory schedules. Actively contributes to best practices and continuous improvement. Represents the group in functional and cross-functional initiatives/projects when required. Identifies opportunities for systems or tools to be used for compliant transfer of figures, tables and other content into regulatory documents. Be a change agent to “make life easier” and “show what’s possible”. Help challenge conventional assumptions to develop and implement new technologies/processes/projects which enhance PTD’s and Roche’s performance. Provide exceptional customer service, technical support, and business services to customers and partners within PTDU and PTR. Qualifications You have a Bachelor’s degree or equivalent with 0-2 years of relevant work experience in editing or writing. Previous technical writing experience preferred. Experience, Knowledge, Skills Demonstrated clear, high-quality scientific writing style in the English language. Experience in regulatory affairs and/or biotech CMC development functions preferred. Experience of authoring and/or editing regulatory documentation preferred. Project management skills: consistently achieves multiple tasks and goals on-time. Strong interpersonal and verbal communication skills. Influencing skills: can influence without authority. Ability to work effectively in a team environment, establishes strong collaborative relationships, resolves conflict by creating an atmosphere of openness and trust. Self-starter. Must possess excellent business acumen, solid judgement, and able to work autonomously from established goals and strategic direction. Able to handle multiple priorities, conflicts, and ambiguity. #J-18808-Ljbffr Genentech

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