Regulatory Medical Writing Specialist

hace 2 días

Madrid, Madrid, España Reconocida Empresa A tiempo completo
Job Summary

We are seeking a highly skilled Regulatory Medical Writing Specialist to join our team at Reconocida Empresa. As a key member of our Regulatory Medical Writing team, you will play a critical role in supporting the development of high-quality clinical documents.

Key Responsibilities
  • Prepare and finalize clinical documents, including clinical study reports, investigator's brochures, protocols, summary documents, briefing books, and regulatory responses.
  • Perform document QC, generate lists of abbreviations and references, conduct literature searches, and other basic tasks.
  • Participate in and lead cross-functional document planning and review meetings.
  • Interact with peer writers and colleagues from other departments.
  • As a lead writer for a compound or document, serve as the primary point of contact and champion for medical writing activities for the clinical team.
  • Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
  • Learn and adhere to SOPs, templates, best practices, policies, and Medical Writing Style Guide.
  • Acquire, maintain, and apply knowledge of the industry, company, and regulatory guidelines.
Qualifications
  • University/college degree required. Masters or PhD preferred.
  • At least 2 years of relevant pharmaceutical/scientific experience; previous regulatory medical writing experience is preferred.
  • Ability to learn and recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in document types under supervision.
  • Attention to detail.
  • Strong oral and written communication skills.
  • Emerging leadership skills, both in time management as well as in project/process management.
  • Able to resolve basic problems independently and complex problems under supervision.
  • Demonstrate learning agility.
  • Able to build solid and positive relationships with cross-functional team members.

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