Your tasks and responsibilities
The primary responsibilities of this role, Senior Manager eDocuments, are to:
Who you are
- Act as Electronic Records/Data Manager, proactively identifying RA data/ document management strategies and needs, ensuring regulatory documents are properly received, stored, tracked and retrievable according to appropriate industry standards and regulatory guidelines covering but not limited to internal SOPs, OIs, ICH guidelines, HA regulations, and legal standards;
- Represent DM on project development teams as it pertains to eDMS procedural and technical regulatory aspects of such projects. This includes, but is not limited to ensuring all relevant guidelines and standards are adhered to and aligned with all other global DM colleagues;
- Ensure adherence to RA aspects of any eDMS system end to end, e.g. development, validation, implementation, maintenance as necessary.
- Implement RA electronic document software system business administrative responsibilities; user accounts, access control/permissions, workflow implementation, templates and end user training;
- Monitor and implement evolving new health authority regulations requiring interactions with Submissions, RA GRSs and all R&D functions contributing to submission relevant documents;
- Provides input to service provider assessments and interacts with service vendors with regards to new applications selections;
- Support and train R&D colleagues, system managers, and RA Process Managers supporting electronic RA information management processes and technologies;
- Ensure critical, effective and proper coordination of regulatory documentation in coordination of regulatory requirements varying from country to country and having numerous worldwide regulatory affiliates.
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:
- Bachelor's Degree required plus eight (8+) years of progressively increasing responsibilities and relevant experience or Master's degree and five (5+) years of progressively increasing responsibilities and relevant experience or PhD and four (4+) years of progressively increasing responsibilities and relevant experience;
- Proven relevant experience may be met via a combination of electronic data/document management, project management, computer systems support, eDMS, Regulatory Affairs, or eDiscovery;
- Extensive experience of eCTD/NeeS regulatory requirements;
- Proven experience with document management systems;
- Experience evaluating and implementing new electronic software;
- Experience training employees on IT-based systems;
- Proven history of training and motivating teams;
- Customer and team orientation;
- Proficiency in Microsoft Office: Word, Excel, PowerPoint;
- Ability to communicate effectively in English both verbally and in writing;
- Ability to analyze and solve problems;
- Ability to prioritize work and support requests.
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/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Country:
United States Location:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.