YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Medical Writing Digital Innovation, are to:
Identify novel digital opportunities and needs in CDO MW related to digitization and automation (advanced modeling, machine learning and AI, digital co-authoring and reviewing platforms, among others), evaluate and prepare decisions for contracting novel digital tools from potential vendors and present to upper management to gain support;
Lead and manage internal initiatives and development projects with focus on digital automation (e.g., PAT initiative, Cognizant's Document Accelerator pilot);
Be responsible for piloting and implementing novel digital tools that facilitate the generation, reviewing, QC, submission and archiving of clinical documents, as well as enhances the collaboration among MW colleagues and adjacent functions (e.g. Statistical Programming, Regulatory Affairs);
Drive the definition of the project's scope, business case development, identification of user requirements in collaboration with internal stakeholders, Request for Proposals, and be accountable for the acceptance of the final product;
Be responsible for monitoring of project progress through following up with other team members and develops and presents update reports for senior stakeholders at Steering Committee Meetings;
Work closely with external vendors and act as the primary communicator and link between internal stakeholders, project teams an external vendors;
Be responsible for communicating with stakeholders across the board, including but not limited to Medical Writing and other CDO functions to make sure the project goals are clear and the project and product vision is aligned with business objectives;
Act as a single point of contact in CDO MW on disruptive technologies and digital solutions, including potential employee concerns about new ways of working and related requirements;
Be responsible for coaching and onboarding MW digital innovation specialists to existing projects;
Initiate and steer the improvement of processes for clinical trials leading to improved efficiency and quality delivery of clinical studies as well as shortens new product's time to market and thus increases additional revenue.
This role is a contractual engagement lasting for 2 years. The preferred locations for this role are: Whippany, NJ, USA, Beijing, China, or Espoo, Finland. Relocation allowance will be offered for this role.
Visa sponsorship may be offered for this role.
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:
Minimum of a Bachelor's degree;
At least five years of experience in the pharmaceutical industry and/or a discipline relevant to the position;
At least three years of experience in a context related to Medical Writing or information technology;
Abilityto deal with process and technical problems across a project;
Notable planning and/or project management experience, ideally in a medical writing/clinical development related function;
Extensive knowledge of and experience with digital tools and systems that can be used in drug development, ideally in a medical writing context, and be motivated and willing to significantly expand this knowledge beyond their currently assigned area of responsibility on their own initiative;
Demonstrate strong communication skills in English, both written and verbal, which are required to articulate concepts and ideas and lead project teams;
Demonstratediplomacity, persuasiveness and abilityto establish rapport with internal and external business partners.
Advanced level of knowledge of clinical trial design, study management, or data management, and a solid understanding of regulatory guidance, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMA), and of current electronic authoring, document management and electronic regulatory submissions.
Bayer is an Equal Opportunity Employer/Disabled/Veterans