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Analyst - Document Support & Training (Global Regulatory Affairs)

 

PURPOSE OF THE POSITION

Analyst – Document Support & Training supports the Global Regulatory Affairs Operations team of Healthcare business.

 

KEY TASKS AND RESPONSIBILITIES

  • Formatting of documents for all disciplines and all products acc to SOP02-RT11-v01 - Technical Submission Readiness of Submission Relevant Documents
  • Creating and updating Virtual Documents (“Digital Dossier”)
  • Creating and verifying bookmark structure and hyperlinks to ensure submission-readiness
  • Supporting stakeholders with need literature via ordering at Scientific Library, formatting, uploading, approving
  • Report publishing for all safety reports, clinical safety management plans as well as nonclinical reports via eldorado publishing tool
  • Point of contact for supporting all stakeholders in eldorado questions
  • Running reports in RIMS for PSMF, changing them from excel to pdf
  • Hands on experience on tools such as eCTD Xpress, ISI Publisher, ISI toolbox for the eCTD, NeeS, Paper Dossiers preparations, validation of dossiers for Health Authorities using tools such as EURs, Lorenz eValidator and handling of validation errors
  • Being able to independently resolve routine issues and most complex issues with minimal guidance
  • Assuring that submission documentation meets registration needs and timelines
  • Regular communication with the client, including, but not limited to, face-to-face meetings, presentations, telephone, email, and conference call interaction.

 

BASIC QUALIFICATIONS

 Education:

  • Degree in a Life Science or related discipline.
  • Understanding of the Regulatory Operations area, including process and technology
  • Excellent spoken and written English.

 

Professional skills and experience:

  • Ability to handle software and databases needed to support the regulatory function according to the role.
  • Excellent knowledge of Microsoft Office
  • Excellent knowledge of electronic Document Management Systems

 

Personal skills and competencies:

  • Ability to work in teams and positively influence team spirit
  • Result orientation and willingness to take ownership
  • Strong customer orientation
  • Strong communication skills

  

 

Job Requisition ID:  192063
Location:  Bangalore SBS
Career Level:  B - Recent University Graduate(<1 year of experien
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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