Associate Director, Scientific Medical Writer

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Associate Director, Scientific Medical Writer

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Associate Director Scientific Med Writer, are to:

• Independently author submission documents and implement the submission authoring strategy under the leadership of the Submission Medical Writer;
• Drive the design of all assigned project level submission documents in support of the Clinical Development Plan (CDP) under the leadership of the Submission Medical Writer;
• Validate the individual study protocol design and clinical study report (CSR) key messages;
• Contribute to the project level data presentation strategy and messaging standards under the leadership of the Submission Medical Writer;
• Mentor Senior Scientific Medical Writers and Scientific Medical Writers in developing expertise in writing 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 (scientific discipline strongly preferred) with at least eight years of pharmaceutical industry experience or a Master's degree in the life sciences and at least seven years of experience in the pharmaceutical industry;
• At least five years of experience in regulatory medical writing, three of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.), preferably in the area of oncology;
• 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 world wide (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:

• Ph.D. in the life sciences and at least five years of experience in the pharmaceutical industry is;
• Have extensive experience in writing clinical documents in support of regulatory submissions globally (i.e. multiple regions) in the area of oncology.