Associate Manager, IT Technical Writing Lead
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Develops documentation for IT functions including Operations, Planning & Controls, Client Technologies and Information Security, as well as supporting programs, initiatives and projects. Scope includes standard operating procedures, policy documents, work instructions, user guides, Visio diagrams, PowerPoint materials or any other document as requested and assigned. Tech Writer creates documentation for both GxP and non-GxP environments and follows the applicable standards and process for each. The Tech Writer is also responsible for maintaining documentation repositories and follows documentation management standards and best practices.
• Manage IT document processes, repositories and quality across all of the IT teams and functions, driving adherence to standards, templates and policy. Balance workload in the team to meet deadlines and ensure strong focus on quality of deliverables.
• Provide support for Computer System Validation requirements, such as the creation of system administration SOPs and other related documentation within GxP system environments.
• Enforce documentation and formatting standards for all document and content types (or develop where absent). Create and maintain libraries of standard reusable documentation objects, templates, and collateral.
• Work with identified technical subject matter expert to develop requested documentation for process, technical area or system within the agreed timeframes. Prepare deliverable agreed within Regeneron IT documentation standards, managing quality and review workflows. Support publication and/or training as required.
• Create and maintain document repositories, or libraries, to categorize and store documentation produced at a project or system level. Use identified toolset to manage version control and the promotion of finalized documents. Apply workflows and automation as needed to assist with the management and approvals of documents.
• Pursue technical knowledge and proficiency in Regeneron systems and technologies, Security, Operations and GxP areas to decrease reliance on SMEs over time.
• Identify new technologies and processes and ensure team's proficiency in documenting these areas.
• Establish and maintain relationships and connections with key IT areas and their processes to ensure documentation triggers are adhered to, and the required documents and deliverables are produced in line with the requirements of these functions and processes (e.g. Communications, Transition, IT Training, Architecture and Engineering).
• Provide editorial review of any documents produced within the team or provided by an external author, to ensure deliverable quality.
• Bachelor's degree in Information Technology or English, or comparable
• Experience managing resources: assigning and monitoring workload, allocating workload based on skillset, identifying training or skill gaps and remediating
• Ability to interface with IT and Business customers, understand content-related requests and manage the delivery of high-quality work
• Proficient in document creation and management technologies including Microsoft Word, Excel, PowerPoint and Visio, Confluence as well as Adobe and SharePoint.
• Working knowledge of applicable business workflows, technologies and systems, including process, security and the Project Management workflows. While prior technical experience is not required, previous experience working with technology and technical documents is required and biotech/pharma is preferred. Experience with GxP preferred.
• Competent in extracting information from subject matter experts and translating into clear text
• Competent in creating and/or documenting workflow and process
• Competent in documenting systems and data flows
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.