Specialist, Document Disclosure
MSDAbout the role
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 provides support to document disclosure group and holds primary responsibility for ensuring the company's compliance with transparency and privacy regulations by collaborating with product development teams to review documents with protected information and redact accordingly.
The responsibilities of the Specialist in Document Disclosure are:
Reviewing and preparing documents to ensure personal protected information is removed.
Facilitating collaborative review with contributing authors and product development team to identify commercially confidential information in documents.
Executing quality checks of documents including the completion of associated justification.
Managing disclosure timelines and participating in submission planning management team meetings.
Monitoring and escalating potential incidences in release of protected information.
Providing input and feedback to the Standard Operating Procedures and Working Instructions for the preparation of documents for public release.
Assist other disclosure efforts and operations (e.g. external data sharing, clinical trial application activities).
Qualifications
Bachelor’s degree in Life Sciences or a related discipline
Required Experience and Skills
Three (3) years of pharmaceutical industry and/or clinical research experience.
Proficiency in the use of a Doc base system or similar Electronic Document Management system.
Experience writing or general understanding of the content of drug and/or device study submission documents.
Knowledgeable in European Medicines Agency's (EMA) and/or Health Canada publication of clinical information requirements.
Preferred Experience and Skills
Highly organized and able to manage multiple projects at any given time.
Attention to detail and dedicated to excellence in all aspects of their work.
Ability to work under pressure, while maintaining a positive attitude
Excellent communication and stakeholder management skills.
Able to work independently and collaboratively in a team environment.
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Current Contingent Workers apply HERE
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