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Bayer Director Submission Medical Writer in St. Paul, Minnesota

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.

Director Submission Medical Writer

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role,Director Submission Medical Writer, are to:

  • Act as the medical writing expert for assigned drug projects and lead the planning, the development and the implementation of the content strategy of clinical submission documents (with input from appropriate expert functions)

  • Drive the design of clinical submission documents in support of the Clinical Development Plan, validates individual study protocol design, key messages of the clinical study report and other clinical submission documents, for assigned drug projects

  • Lead the development of the project level data presentation strategy and messaging standards

  • Lead the team of medical writers supporting the clinical submission documents for assigned drug projects

  • Author independently submission documents and work with assigned Associate Submission Writers and Senior Scientific Medical Writers and other submission team experts in developing and implementing the submission authoring strategy for all clinical documents

  • Work with Head MW Submissions and the Head MW Studies to develop and implement authoring resource plans for all clinical submission documents of assigned drug projects

  • Maintain current knowledge on all regulatory agency medical review guidelines and drug approval requirements for assigned projects

  • Mentor Associate Submission Medical Writers and Senior Scientific Medical Writers in developing expertise in managing and writing and submission documents

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:

Required Qualifications:

  • Bachelor’s degree with at least 10 years of pharmaceutical industry experience or Master's degree in the life sciences with at least 8 years of experience in the pharmaceutical industry

  • At least 6 years of experience in regulatory medical writing, four of which should be in writing submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.)

  • Have extensive experience in writing clinical documents in support of regulatory submissions globally (i.e. multiple regions)

  • Have relevant experience in managing and mentoring medical writers and must have successfully led medical writing teams developing the clinical sections of CTD dossiers

  • Have a thorough knowledge of the pharmaceutical industry, including understanding the drug development process and associated documents and regulations

  • Specific knowledge of the clinical study protocol and clinical study report development process, regulatory and drug safety requirements and clinical data management and statistical processes/functions

  • Have an in depth understanding of all applicable scientific and regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g., ICH, FDA, EMA, CFDA)

  • Have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions, tools and standards

  • Demonstrate outstanding communication skills (fluency in English, written and verbal) required to articulate concepts and ideas

  • Be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Oncology SBU organization

  • Ability to establish internal and external collaborations, including commitment towards external visibility

  • Native verbal and written English communication skills

Preferred Qualifications:

  • Degree in a scientific discipline

  • Ph.D. in natural sciences with at least 6 years of experience in the pharmaceutical industry

  • Experience in the area of Oncology

YOUR APPLICATION

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. 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.

Location: United States : New Jersey : Whippany || United States : Residence Based : Residence Based

Division: Pharmaceuticals

Reference Code: 284641

Contact Us

Email: hrop_usa@bayer.com

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