In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
Full Time
Travel: No
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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
Detail-Oriented
Deadline-Oriented
Communicator
Organized
Versatile
Tech-Savvy
Rewards
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
Work-life Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Career Development
Opportunity to learn and grow through a performance and development goal-setting program.
Home based
Love where you work, and work where you love.
Variety
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Associate Medical Writer
Basic experience/understanding of Clinical Trial Disclosure/Clinical Trial Transparency. The candidates with the below experience would be preferred.
Experience handling regulatory websites such as ClinicalTrials.gov, EudraCT/ Clinical Trials Information System (CTIS), and European Union electronic Register of Post-Authorization Studies (EU PAS Register)
Protocol Registration/ Maintenance for ClinicalTrials.gov and EU PAS Register
Results postings for ClinicalTrials.gov, EudraCT/ Clinical Trials Information System (CTIS), and European Union electronic Register of Post-Authorization Studies (EU PAS Register)
Plain language summaries (for distribution to study participants, posting on customer websites or upload onto the EMA portal as per the EU Clinical Trials Regulation 536/2014 [Article 37])
Anonymisation and Redaction (EU-CTR (CTIS), EMA Policy 0070, Health Canada (PRCI), ClincalTrials.gov, EU PAS Register)
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