JOB POST: Clinical Medical Writer at Xogene [Remote]: Apply Now!

Xogene invites application from qualified candidates for the post of Clinical Medical Writer at Xogene [Remote]

About

Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements. Since 2010, Xogene has been offering a suite of transparency services to meet evolving regulatory needs, from helping to build a newly emerging transparency capability to augmenting an already mature process.

Education Qualification

  • Work authorization
  • Advance Degree in Medicine, Pharmacology, Biology or related scientific discipline; Masters degree preferred
  • 3+ year(s) clinical medical writing experience or scientific writing with a pharmaceutical or biotechnology company or a contract research organization
  • Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
  • Understanding of FDA/EMA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production (including CTDs)
  • Expertise in analytical evaluation of scientific data, organizational skills, and the ability to work in a team environment
  • Knowledge of plasma derived therapeutic areas (products and therapies) or related scientific areas
  • Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
  • Strong computer skills with Microsoft Word, Excel, PowerPoint and Adobe (or any other PDF-related program)
  • Meticulous attention to detail
  • Intercultural understanding with a global perspective

Job Role

  • Develop/write clinical documents for submission (especially investigator brochures, protocols, clinical study reports, post-study documents such as ISS, ISE, Clinical Summaries, Clinical Overview), ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
  • Oversee development/writing of clinical documents for submission (especially protocols, CSRs) by external service providers, ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
  • Provide key messages on the interpretation of clinical study results to external service providers for the development of clinical documents such as CSRs.
  • Ensure compliance of clinical documents with national and international regulatory agency regulations/guidelines and departmental standard operating procedures.
  • May write/review/prepare briefing books, product labels, and responses to regulatory agencies’ inquiries regarding products to support franchises.
  • Work closely with clinical teams on assigned projects to ensure adherence to timelines.
  • Ensure that all compositions conducted under his/her/their responsibility are performed within time, quality and cost expectations and in a manner that is both ethically and legally acceptable to all regulatory agencies.

Job Location

Remote – US or EU based

Click here to apply and view the official notification for the post of Clinical Medical Writer at Xogene.

Responses

Your email address will not be published.

Advertisement