Specialist Disclosure Medical Writer Job at Idaho State Job Bank in Boise

Specialist Disclosure Medical Writer at Merck in Boise, Idaho, United States Job Description Job Description The Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers. The Specialist (Disclosure Medical Writer) will be primarily responsible for preparing clinical study registration and results disclosure postings in compliance with company policy and country laws and requirements. The disclosure team works collaboratively and independently to prepare disclosure documents for clinical studies in all therapeutic areas. The Specialist will be responsible for: + Authoring scientifically valid clinical trial registration and results postings on (United States NIH public disclosure registry), the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) registry, and The Heads of Medicines Agencies (HMA)- European Medicines Agency (EMA) Catalogue of Real World Data (RWD) Studies (formerly EU PAS) registry for studies of varying complexity and therapeutic designation. + Preparing study registration and results postings based on source documents (e.g., protocols, CSRs), negotiating content with internal and external reviewers, and guiding the posting through review and approval. + Collaborating with clinical teams, including requesting necessary data and information, to ensure compliance with applicable legal requirements (Section 801 of the Food and Drug Administration Amendments Act and the Final Rule for Clinical Trials Registration and Results Information Submission [42 Code of Federal Regulations Part 11] in the US, and Directive 2001/20/European Commission and the Clinical Trials Regulation of the European Union). + Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate and incorporating review findings prior to finalizing for posting on public websites; and addressing NIH Quality Analysis review comments to resolve issues before resubmission when necessary. + Participating in weekly MW&D-Disclosure meetings and scheduling meetings as needed with external teams. + Assuring that Project Leads and management are informed of any problems or unresolved issues that could affect the timely completion of the work or the work quality. + Gaining expertise in the regulations associated with the disclosure of To view full details and how to apply, please login or create a Job Seeker account