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.

 

Scientific Medical Writer 

 

Position Purpose:       

The Scientific 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.

 

 

Geographical Scope: Global

 

Major Tasks of Position:         

He/She implements the content strategy for all study level clinical documents as assigned.He/She drives the design of all assigned study level documents in support of the Clinical Development Plan, if applicable under the leadership of MW Strategist or Submission 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.

             

Value added to the success of the company: 

Scientific Medical Writer acts as the medical writing expert responsible for the authoring, technical writing and editing of study level documents assuring compliance, quality and timely preparation.

 

 

Work Interactions:     

He/She interacts with contract research organizations 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, Study Manager, Medical Expert, 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.

 

Qualifications:             

This position requires a Bachelor’s degree and a minimum of 4 years experience in the pharmaceutical industry, or a Master degree and a minimum of 2 years experience in the pharmaceutical industry, or a PhD.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 electronic authoring, 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.  YOUR APPLICATION   

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer. 
 
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
 

 

 

Location:

Spain : Cataluña : Barcelona  

 

Division:

Enabling Functions 

 

Reference Code:

839338