Scientific Medical Writer - Global Pharma company - (Clinical Trial) - Germany (Wuppertal)
Responsible author and also takes care of the technical formatting and editing of documents for the planning, execution and reporting of clinical trials.
Responsible for the complete life cycle of clinical trial documents, such as protocols and amendments, clinical trial reports and their amendments, specific country analysis reports, ethnic sensitivity reports, and the provision of clinical results for publication by regulatory authorities.
- He/she implements the specified development strategy in all assigned study documents.
- He/she designs the study design according to the clinical development plan, if necessary under the guidance of a Medical Writing Strategist or Submission Medical Writer.
- He/she is the responsible author of the study documents and integrates the contributions of the study team, ensures that the study results are presented in a comprehensible way in text, tables, and graphics, uses the required standards, and compares the key messages with the specified strategy.
- She/he is responsible for the format and content of the study-specific documents assigned to her/him and for their compliance with global regulatory requirements and electronic publication standards.
- She/he works with contract research organizations and individually commissioned medical writers and ensures that externally commissioned documents are completed in a timely manner and in accordance with sponsor standards.
- He/she works with the relevant study team (i.e. operational, clinical and pharmaceutical specialists) to develop and finalize documents relevant to the study and supports the processes required for document management.
- He/she cooperates with the departments responsible for regulatory filings and drug approvals to ensure that all study-relevant documents assigned to him/her meet the required internationally recognized technical regulatory standards.
Interested and want to learn more? Get in touch with Ryan Goodland at MSI Pharma
(phone number removed)
- Πλήρης απασχόλησης
- EUR 2.900 / Μήνας