Associate Medical Writer

5 days ago

Remote, India Parexel Full time

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

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
- Glassdoor Reviews and Company Rating

**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**
- 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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