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 Scientific Medical Writer
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Manager Scientific Medical Writer, are to:
- Implement the content strategy for all clinical documents as assigned;
- Drive the design of all assigned study level documents in support of the Clinical Development Plan (CDP) under the leadership of Submission Medical Writer;
- Author study level documents (collaborating with the team), implements project-level data presentation and messaging standards for the assigned documents, validates individual study protocol, design and clinical study report (CSR) key messages based on the strategy provided;
- Be accountable for the format, content, and adherence to global regulatory guidelines and electronic publishing standards of the individual clinical documents that this role authors.
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 in Natural Sciences with a minimum of four years of experience in the Pharmaceutical industry or a Master’s degree in Natural Sciences with a minimum of two years of experience in the Pharmaceutical industry or a Ph.D. in Natural Sciences;
- Understanding of the overall drug development process;
- Knowledgeable of the clinical study report development process, regulatory and drug safety requirements, and clinical data management, and statistical processes/functions;
- Demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas, be diplomatic, be persuasive, and be able to establish rapport with all key functional leaders and experts in the SBU Oncology organization.
- Master’s degree and Ph.D.;
- Working knowledge of current electronic authoring, document management, and electronic regulatory submissions.
Domestic Relocation may be offered
Reference Code: 116941
Functional Area: Clinical Development & Operations
Entry Level : Professional