The department Global Regulatory Communication Management (BCM) creates or supports the creation and distribution of internal communication and information within Global Regulatory Affairs (GRA) and between GRA and the Regulatory Affairs People in the Local Operating Companies.
The department is also responsible for Business Change Management activities within the areas of responsibility of Global Regulatory Communication, Compliance and Operations.
This position will provide support for relevant communication and knowledge sharing activities, training in the services provided by the department and input to the continuous development of internal regulatory information and communication services within the responsibility of Takeda Global Regulatory Affairs.
This position ensures maintenance and global support of the intranet pages owned by Takeda Global Regulatory Affairs and / or other relevant communication media in close cooperation with the person responsible for the GRA intranet.
This role participates in Business Change Management (BCM) activities related to systems, IT projects, processes as relevant within Global Regulatory Communication, Compliance and Operations. This is done in close cooperation with the person responsible for Business Change Management in Roskilde, Denmark and with the persons responsible for the area/projects.
- Support in connection with Global RA Conference and/or workshops/meetings with the LoCs
- Host “knowledge sharing sessions” for GRA personnel - local and global
- Inform and train Regulatory Affairs People in the services provided
· Communication support activities
Information Media and Material
- Maintain and support the function as well as the departmental homepages and/or other relevant communication media in close cooperation with the person responsible for GRA Intranet
- Maintain and provide proactive input for further development of key regulatory information such as e.g. Welcome material, intranet pages
- Create or facilitate creation of, distribution and development of information material such as e.g. News, Newsletters, guides
Business Change Management (BCM)
- BCM activities in the service areas of Global Regulatory Communication, Compliance and Operations - systems, processes
- Support internal communication as part of the BCM activities
- Ensure that the relevant amount of information / tools are made available using relevant media
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education and Experience Required:
- Bachelor’s degree
- Knowledge of pharmaceutical and regulatory affairs requirements and practices
- Practical operational experience of working across disciplines and across multiple regions
- Knowledge of communication theory/practice, Business Change Management and project management
- 5 + years experience in Regulatory Affairs or Pharmaceutical industry
- Strong skills in written and verbal communication (English)
- Experience in the development, implementation and maintenance of homepages and/or other communication media
- Facilitator as well as team player with excellent interpersonal skills
Education and Experience Preferred:
Skills and Knowledge Desired:
- Industry Knowledge – understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes including high level Regulatory Affairs processes.
- Systems Knowledge – experience within Communication theory/practice, Business Change Management and project management
- Regulatory Familiarity – knowledge of European, US and international regulations relative to activities covered in regulatory affairs in order to facilitate communication activities as relevant
- Takeda Operations – Ability to work effectively with any internal and external Takeda department.
- Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
- Communication – ability to express oneself clearly and concisely to a variety of audiences
- Team Working - Ability to work with team members in a friendly, professional manner - across countries.
- Independent - ability to work independently (being part of a department placed in Roskilde, Denmark)
- Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use.
- Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
- Goal oriented and customer focused
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Ability to sit or stand for long periods of time while traveling.
Willingness to travel to various meetings / trainings including overnight trips. International travel may be required.
We are driven to improve people's lives.
We are an equal opportunity employer.
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