<p>Working closely with the Senior Manager of Quality Assurance, the Document Control Manager will be instrumental in developing and championing INCOG's approach to the design, approachability, control, and training of content; ultimately being a major contributor for the Integrity of the management of data/information at the site. The Document Control Manager will manage the team responsible for the flow of documents, records, and subject matter experts, and own the logistical operations for all site inspections.</p> <p>The Document Control Manager will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Document Control Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Document Control Manager will have strong familiarity with Microsoft word processing and spreadsheet management software. They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. They will have demonstrated leadership skills in the management of workflows of other teams and will have an understanding of the development of team goals, metrics, and culture. The Document Control Manager will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes. They will have demonstrated working relationships with client and prospective client representatives and will have shown an appreciation for the sensitivity of confidential and proprietary information of both clients and the internal organization.</p> <p>Essential Job Functions:</p> <ul> <li>Assume the role of INCOG Data Integrity subject matter expert and point of contact, alternate to the Sr. Manager. </li><li>Administrate the routing, review, release, and retirement of controlled documents in an electronic document management system. </li><li>Administrate the issuance, control, and reconciliation of a controlled copy and record program including Batch Records, Logbooks, Controlled execution forms, and stationed/posted materials. </li><li>Maintain the design and perform the training of new employees on the requirements and significance of Good Documentation Practices, as well as controlled document and records management. </li><li>Maintain the design and perform the training of employees on the routing, change management, and approval requirements for controlled documents. </li><li>Maintain site licensure documentation and coordinate renewal routing in conjunction with the QA Compliance department. </li><li>Lead the logistics activities for client and health authority inspections, including maintaining documents, records, and other logistics in a state of continual inspection readiness. </li><li>Administrate the Periodic Review of controlled documents program. </li><li>Administrate the annual logbook, offsite records, and controlled issued documents review cycles. </li><li>Organize and lead the Document Control Technicians and Specialists in their support of all applicable programs, provide them mentorship, and design and support their annual and career development goals. </li><li>Manage the processes for the repository and routing client-related controlled documents and the provision and of client-related records. </li><li>Establish and manage Document Processing activities, inclusive of providing internal customer support on navigating and working within that process. </li><li>Establish and manage an offsite Records Management Program. </li><li>Plan and execute the outfitting of INCOG's long-term Records Archive Room. </li><li>Scope-out and plan and implement, in conjunction with the QMS Administrator, all eDMS functional advancement. </li><li>Provide technical writing and information design support in document authoring and document hierarchy decision-making. </li><li>Provide technical support and tips and tricks to internal and external customers on the Veeva electronic Document Management System and for Microsoft Office product(s) usage. </li></ul> <p>Special Job Requirements:</p> <ul> <li>Bachelor's degree in a scientific or language/communications/data management field. </li><li>Minimum of 8 years' experience in a regulated industry, 4 within the Pharmaceutical industry. </li><li>Minimum of 3 years' experience as Administrator of an electronic Document Management System. </li><li>Minimum of 3 years' experience in records management, i.e. issuance and reconciliation processes and storage controls. </li><li>Minimum of 6 years' experience designing, writing, and/or editing documents of a technical nature. </li><li>Minimum of 3 years' experience with internal customer service, support/troubleshooting and/or training/presenting publicly. </li><li>Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel. </li><li>Able to lift and move boxes of up to 50 lbs and stand for moderate periods of time. </li></ul> <p>Additional Preferences:</p> <ul> <li>Certification in Technical Writing or Information Management. </li><li>Microsoft Office Manager or Expert certification in Word and/or Excel. </li><li>Moderate to expert level experience with Microsoft PowerPoint, Visio and/or other presentation software packages. </li></ul> <p>Additional info about INCOG BioPharma Services:</p> <p>At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.</p> <p>If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.</p> <p>INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. ?All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.</p> <p>By submitting your resume and details, you are declaring that the information is correct and accurate.</p>