Bayer Global Document Management Specialist in Whippany, NJ, New Jersey
Your tasks and responsibilities
The Primary Responsibilities of this role, Global Document Management Specialist, are: • Reviews, verifies and enters all Regulatory Authority submission documents (e.g. IND, NDA/sNDA, MAA, CTD/eCTD, CTA/IMPD, PSUR, Agency Meeting Briefing Packages, Major variations, Product renewal, CMC amendment, IND/NDA annual reports, information amendments, DMf update, etc.) into Official Regulatory global database and ensures documentation is in accordance with both domestic/international Regulatory Authority regulations/guidelines and Bayer SOPs; • Executes independently very difficult and complex regulatory documentation searches to extract data and statistics, export documentation, and create listings and reports for the on-going operations/projects of the Regulatory Affairs and the Global Document Management Departments which includes litigations, due diligences, integrations, audits, and co-partner activities; • Coordinates and leads document exchange, scanning, quality control, assembly and committing of all regulatory authority submission, compliance, correspondence, advertising and promotional documents into Bayer’s eDMS (global electronic archival system) for product purchase activities, integrations and Regulatory projects. Develops electronic table of contents for large submission documents to provide easy access to document images; • Incumbent assists in the preparation, validation, implementation, and maintenance of the global Regulatory electronic database (ShareDoc); • Perform high functioning technical skills and works independently on various DM software tools. Also assists in the development and maintenance of operational guidelines and best practices in accordance with Health Authority Regulations and Bayer’s global standard operating procedures; • Problem-solve, interact, communicate, and address daily issues from various levels of international colleagues and customers regarding document management software and records management responsibilities; • Performs the compilation of Medical Research Reports (MRR) that includes an internal technical review of the published result according to the current regulatory requirements; • Trains, allocates, and distributes work to other global Document Management & Archiving Department staff.
Major tasks and responsibilities of position: • Leads the review and verification of daily workflow processes to insure all domestic and international submission type documents (e.g. IND, NDA/sNDA, MAA, CTD/eCTD, CTA/IMPD, PSUR, Agency Meeting Briefing Packages, Major variations, Product renewal, CMC amendment, IND/NDA annual reports, information amendments, DMf update, etc.) are entered into DM Official global database and are in accordance with both domestic/international Regulatory Authority regulations/guidelines and Bayer SOPs; • Reviews with Regulatory personnel the document requirements, data changes, and document deadlines for entry into the Bayer Global enterprise system. Brings discrepancies to management's attention and makes the necessary changes to the database in an efficient and timely manner; • Coordinates and leads the scanning, quality control, assembly and committing of all regulatory authority submission, compliance, advertising and promotional documents into an eDMS global electronic archival system. Develops electronic table of contents for large submission documents to provide easy access to document images; • Tracks, maintains, and ensures that all information and metadata required for Regulatory Authority inquiries, audits, integrations, and legal activities is thorough and accurate, and reports and electronic images can be created and provided domestically and internationally on a priority basis; • Co-develops with appropriate Bayer personnel the guidelines/user manuals for Document Management related processes and procedures, global databases and special application systems; • Takes a leadership role in handling all mechanical/technical problems, maintenance, and i
Who you are
Required Qualifications Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: • Associates Degree or equivalent with at least 4 years of progressively increasing experience, 3 years of which must be direct regulatory and IT/technical experience; • Regulatory Affairs relevant data and direct document and records management experience with Regulatory related databases and computer systems is a must; • A thorough knowledge and understanding of submission documentation such as IND, NDA, DMF, CTA, and NDS and other related material is essential; • An understanding and exposure to information required for global regulatory submissions and/or systems used in regulatory submissions is highly desirable; • An excellent working knowledge of regulatory databases (ShareDoc, Contact, Documentum, Impact) is a plus; • Must be fully cognizant of and responsive to shifting individual and departmental priorities; • Strong interaction and communication skills with professional staff at all levels within Bayer worldwide and effective written skills are necessary; • Willingness and ability to travel as needed, up to 5%.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled