Technical Writer II

Profile

Onsite! Client MSAT Position Client-Client has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Our portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a part of Client, we benefit from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. The position is part of Process Science in Global Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston, MA. The global MSAT team is within the Industrial Affairs (IA) unit of Client-Clients Specialty Care organization. The Team is responsible for providing laboratory-based technical support to Client biologics. The Team recently designed a state-of-the-art laboratory with capabilities to support small-scale models of the commercial cell culture and purification operations, as well as analytical testing. The Process Science team member will be: Responsible for designing, developing, and updating required technical documentation. Responsible for technical writing/editing for all types of documentation produced within a commercial manufacturing environment. Utilize knowledge of word processing software, strong writing and analytical skills to document qualification, manufacturing, and validation activities. Track and review change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Review current documents - incorporate comments from Manager. Navigate through Client documentation system utilizing current templates. Notify manager of workflow status and issues. Incorporate comments from team members and provide status to manager on review and approval workflow. Follow up with team members on comments. Skills: Technical writing abilities and good time management. Strong root cause analysis skills with experience regarding quality standards. Be able to establish working relationships with other support and production areas in order to gather all the necessary information required. Must be proficient with a working knowledge of templates, workflows, and approval process. Proficient in MS Word, Excel, PowerPoint, and Outlook. Interact well with a diverse group of individuals. Self-motivated and willing to be proactive in resolving issues. Excellent verbal and written communication skills. Ability to work in a team environment. Ideal candidate would have a technical understanding of basic biopharmaceutical manufacturing principles. Education: University graduate preferred. Years of Experience: 2 - 6 Years

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