Medical Writer Ii

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.

**Job Purpose**: Under departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of **PBRER/PSUR** for submission to regulatory authorities.

The Medical Writer would serve as the primary client contact.

The Medical Writer **must have minimum 2 years** of experience in authoring or supporting PBRER/PSUR

**Key Accountabilities**:
**Author PBRER/PSUR**:

- End-to-end authoring of PBRER/PSUR
- Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize PBRER/PSUR for submission to regulatory authorities.
- Revise PBRER/PSUR drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Author Safety sections for the PBRER/PSUR and perform case level analysis of the retrieved cases
- Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable.
- Perform literature reviews to obtain background information pertaining to the safety topic analysis.

**Quality Control**:

- Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Confirm data consistency and integrity across the document.
- Prepare documents for publishing readiness, when applicable.
- Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable.
- Provide suggested alternative content when contributors provide content that does not meet document needs.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.

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