Medical Writer

YOUR TASKS AND RESPONSIBILITIES

The Medical Writer acts as the medical writing expert responsible for the authoring, technical writing and editing of study level documents.

He/She provides lifecycle support for clinical study document preparation, including but not limited to clinical study protocols and amendments, clinical study reports and amendments, country analysis reports, ethnic sensitivity reports and results posting.

Responsibilities include assuring compliance, quality and timely preparation of clinical documents as assigned.

He/She interacts with contract researchorganizations and individual contract medical writers regarding writing projects that have been contracted outside of Bayer, to ensure the medical writing deliverables meet all Bayer standards.

He/She interacts with the document review team (e.g. for the clinical study report, the review team mainly includes: Clinical Leaders, Clinical Pharmacology Leader, Clinical Operations Manager, and Statistician) to help facilitate the document management process.

He/She interacts with the global submissions group to ensure all documents submitted for final electronic publishing meet all required technical and eCTD standards.

He/She implements the content strategy for all clinical documents as assigned.

He/She drives the design of all assigned study level documents in support of the Clinical Operations Roadmap, if applicable under the leadership of Senior Principal Medical Writer.

He/She independently authors study level documents (collaborating with the team for content input), implements project level data presentation and messaging standards for the assigned documents, validates individual study protocol design and clinical study report key messages based on the strategy provided.

He/She is accountable for the format, content and adherence to global regulatory guidance and electronic publishing standards of the individual clinical documents that he/she is the author of.

WHO YOU ARE

Bachelor’s degree and a minimum of 4 years experience in the pharmaceutical industry, or a Master degree and a minimum of 2 yearsexperience in the pharmaceutical industry, or a PhD.

Excellent English skills and Fluency in Japanese PhD in natural sciences or equivalent degrees are highly preferred.

The incumbent must have a thorough understanding of the overall drug development process.

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

Working knowledge of current electronicauthoring, document management and electronic regulatory submissions is highly preferred.

The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.

The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the Pharma Research & Development organization.

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