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
Check out the top traits we’re looking for and see if you have the right mix.
"I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,Christine, Medical Writer II
knowledgeable, and it is easy to communicate with other staff."
"Parexel makes it easy to communicate and interact with each other, which allowsKristy, Associate Manager
me access to expertise and knowledge beyond my own."
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Opportunity to learn and grow through a performance and development goal-setting program.
Love where you work, and work where you love.
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Currently hiring a Principal Clinical Regulatory Medical Writer to work remote from any location in the US. (Full time)
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.
Excellent interpersonal, negotiation, verbal, and written communication skills.
A flexible attitude with respect to work assignments and new learning.
Motivation to work consistently in a fast-paced, rapidly changing environment.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
Understands and satisfies client needs.
Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.
Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.
Knowledge and Experience:
Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects.
Must have experience as the Primary author, ( wrote majority of content, provided document project management), working on the following documents: Patient Narratives; Informed Consents; Investigator Brochures; Full Protocols; Full Clinical Study Reports; Clinical Overview (Module 2.5); Clinical summaries (Modules 2.7.3, 2.7.4; ISS, ISE); other clinical and regulatory documents.
Knowledge of resource management and productivity metric management.
Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
Ability to travel.
Fluent in written and spoken English.
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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