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.
- Full Time
- Level: Mid
- 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
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Work-life Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Career Development
Opportunity to learn and grow through a performance and development goal-setting program.
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Home based
Love where you work, and work where you love.
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Variety
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Responsibilities
The Principal Medical Writer, will research, create, and edit all documents associated with clinical research. The Principal Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Principal Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input.
Minimum Qualification Requirements:
- Candidate must have 10+ Years experience in regulatory medical writing. Experience in authoring protocols, clinical study reports, investigator’s brochures, informed consent forms, summary documents, etc.
- Experience in multiple therapeutic areas, including but not limited to vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology oncology, etc.
- Strong communication and interpersonal skills.
- Bachelors/advanced degree or equivalent education/degree in life sciences/healthcare.
- Experience from the pharmaceutical /CRO industry.
- Ability to work independently and lead projects.
- Strong analytical skills.
- Commitment to highest quality outputs, including high attention to detail.
- Ability to manage variable workload.
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