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Specialist Disclosure Medical Writer
$83,100 - $130,900/Yr
Merck KGaA Darmstadt Germany - Boise, ID
posted 2 months ago
Full-time - Mid Level
Onsite - Boise, ID
Chemical Manufacturing
About the position
The Specialist Disclosure Medical Writer at Merck is responsible for preparing clinical study registration and results disclosure postings in compliance with company policies and legal requirements. This role involves collaborating with clinical teams to ensure accurate and timely public disclosures of clinical trials and their results across various regulatory platforms.
Responsibilities
- Authoring scientifically valid clinical trial registration and results postings on public disclosure registries such as ClinicalTrials.gov, EudraCT, and HMA-EMA Catalogue of Real World Data Studies.
- Preparing study registration and results postings based on source documents, negotiating content with internal and external reviewers, and guiding the posting through review and approval.
- Collaborating with clinical teams to request necessary data and information to ensure compliance with applicable legal requirements.
- Responding to internal and clinical review comments on public disclosures and amending disclosures as appropriate before finalizing for posting.
- Participating in weekly MW&D-Disclosure meetings and scheduling meetings with external teams as needed.
- Informing Project Leads and management of any problems or unresolved issues that could affect the timely completion of work or work quality.
Requirements
- Experience in medical writing or a related field, particularly in clinical trial documentation.
- Strong understanding of regulatory requirements for clinical trial registration and results disclosure.
- Excellent written and verbal communication skills.
- Ability to collaborate effectively with cross-functional teams and external stakeholders.
Nice-to-haves
- Familiarity with clinical trial protocols and clinical study reports (CSRs).
- Experience with public disclosure registries and regulatory submissions.
Benefits
- Health insurance coverage
- 401k retirement savings plan
- Paid holidays
- Professional development opportunities
