Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Manager Document Quality
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Manager Document Quality, are to:
- Edit and format, support the authors with respect to eSubmission readiness, data presentation, and writing style/language for the assigned submission documents including submissions for market approval and regulatory document packages for Health Authority interactions;
- Coordinate Quality Control and technical support activities for the assigned submission projects with the Development Medical Writing (MW) Specialists;
- Train and support the Medical Writers and submission teams in technical and process requirements, and in operating MW-relevant systems and tools;
- Develop and maintain regulatory document templates;
- Maintain current knowledge on all system/tools, technical and formatting requirements, and publishing standards for assigned submission projects;
- Provide resource estimates and timelines for the assigned submission projects to the Development MW Operations Manager for planning and assigning of MW Specialist resources;
- Train and mentor Development MW Specialists in developing oncology-specific technical, and process expertise.
WHO YOU ARE
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 with at least four years’ experience in the pharmaceutical industry, or a Master’s with at least two years’ experience in the pharmaceutical industry;
- At least three years of experience as Medical Writing Specialist, publisher or other relevant technical experience, and demonstrate in-depth knowledge of medical writing processes and systems;
- Excellent working knowledge in current electronic authoring, document management, and electronic regulatory submission;
- Demonstrate strong English communication skills, both written and verbal required to articulate concepts and ideas;
- Ability to be diplomatic, persuasive, and able to establish rapport with all key functional leaders and experts in the SBU Oncology Development organization.
Domestic relocation may be offered.
State: New Jersey
Reference Code: 116961
Functional Area: Clinical Development & Operations
Entry Level : Professional