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Sr Medical Writer

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Novato, United States NetEffects Full time

Overview Training Associate. This is a hybrid role. Must work onsite in Novato 2 days per week. Worker must be onsite on Tuesday or Wednesday and can choose the other onsite workday. 5 month contract. Pay Range: $40.00 - $42.75. Job Summary Effective training programs are critical in a regulated manufacturing business, and this position plays an essential role in ensuring the training administration for BioMarin manufacturing and support groups are compliant with regards to GxP, regulatory and industry standards and guidelines. The Training Specialist's primary function is to ensure our learning management system is effective and efficient. He or she will interact with customers to streamline curricula within the LMS. They will ensure that customers are adequately credited for the training necessary to properly and consistently perform their functions and assist in identifying and implementing improvements to processes that will lead to gained efficiency and reduce costs. This position reports on the training function within the Business Operations department and supports the Novato manufacturing site and its support groups. Responsibilities Administration of the Learning Management System (LMS) to ensure seamless customer experience for the users of BioMarin manufacturing and manufacturing support groups Provision of training reports in support of audit and inspection Leading or assisting department projects as needed LMS Administrative Requests Building training curricula in association with the customer department/group Supporting project on migrating to paperless credit system Processing of training assignment requests, including curricula and user group creation and modification Processing Node structure changes and the associated re-grouping of personnel Entering training record data for non-LMS driven activities Integrating multiple types of e-Learning training modules into the LMS Creation, editing and archive of documentation as directed by department management Creation and delivery of custom reports as requested Maintain and update training database Additional Responsibilities Participate in internal and external audits and inspections Review documents (SOPs) and TNAs, provide feedback on the contents, and assess the training needs and requirements for new and revised procedures. Supporting department logistics as needed Deliver training as applicable Interact with customers across manufacturing and support groups to address technical support inquiries Train on administrator tools and an ad-hoc and planned basis Guide/educate customers in the design of curricula and the associated implementation in the LMS to maximize efficiency and ensure consistency across learning content Support department logistics as needed Identify and recommend process improvements Lead or support improvement projects for training systems or programs Required Skills Administration of the LMS (ComplianceWire, Veeva, SAP etc.) Application of data integrity best practices in a corporate environment Use of web-based database software applications Effective customer service across all levels of business Desired Skills 2-4 years in a regulated environment supporting highly technical processes (e.g. life sciences, energy, aviation, nuclear industries) 4-6 years of experience in professional training Excellent written and verbal communication skills Ability to comprehend technical information related to equipment, process and regulatory expectations Familiarity with Biotech, Pharmaceutical and/or Medical Device Industry Microsoft Office Suite Excel, Outlook, SharePoint, Visio, Word Education Bachelors Degree in technical discipline preferred (biological sciences preferred, but not required) Benefits (employee contribution) Health insurance Health savings account Dental insurance Vision insurance Flexible spending accounts Life insurance Retirement plan All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #J-18808-Ljbffr