Regulatory Writing for US based MNC

Location
Industry
Contract Type
Permanent
Published
Contact
Reference
29-25-8168
Academic title
Bachelor of Science
This position is archived.
This position is archived.
Job description
  • Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
  • Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
  • Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
  • Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
  • Ensure data are presented in a clear, complete, accurate, and concise manner.
  • Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
  • Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
  • Ensure and coordinate quality checks for accuracy.
  • Exhibit flexibility in moving across development and preparation of multiple document types.
  • Influence or negotiate change of timelines and content with other team members.
  • Work with internal and external experts to develop and prepare presentations.
  • As needed, may build and manage relationships with vendors/alliance partners.
Requirements
  • Provide coaching to others by sharing technical information, giving guidance, answering questions.
  • Recognized for technical expertise in specific document development.
  • Network with others (including other functions and regions) to identify and share best practices.
  • Contribute to process improvements, suggesting opportunities where appropriate.
  • Provide database and other tool (e.g., document management systems) expertise.

Minimum Qualification Requirements:

  • Bachelor’s degree in a scientific, health, communications, technology health related field.
  • Demonstrated experience in technical/ regulatory scientific writing.
  • Strong communication and interpersonal skills.
  • Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)
  • > 6 years experience in Medical Writing.

Other Information/Additional Preferences:

  • Graduate degree with formal research component or in life sciences.
  • Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields.
  • Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).
  • Experience writing regulatory, clinical trial documents and/or publications
  • Experience in clinical development, clinical trial process or regulatory activities.
  • Demonstrated project management and time management skills.
  • Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).
Benefits

Excellent Compensation

  • Global Exposure
  • Visible Career Path
  • General Shift
  • 5 Days Work
Other notes
For more related job opportunities visit https://www.elixir-consulting.com/en/job-search
This position is archived.
This position is archived.