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.
Check out the top traits we’re looking for and see if you have the right mix.
"I am part of a great team! My colleagues at Parexel are a pleasure to work with, areAnne-Christin Friedrich - Senior Medical Writer
knowledgeable, experienced, caring and always ready to help!"
"I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,Christine Simmons, 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 Haslerud, Associate Manager
me access to expertise and knowledge beyond my own."
"Since the day I started, I have learnt something new from people on my team: it can be something associated with medical writing, the latest technology, or a tool that enhances/ aides writing."Erangi Tennakoon, Medical Writer II
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.
• The SMW gathers, reviews, analyzes, and evaluates pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.
• It has to be ensured that all work is complete and of high quality prior to team distribution or shipment to client; referring to data consistency and integrity, publishing readiness, adherence to regulatory guidelines, compliance with departmental, corporate or client SOP's and style guidelines.
• The SMW acts in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
• Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOP's. Distribute final documents to project team and client.
Qualifications• Excellent interpersonal, verbal, and written communication skills.
• Ability to consistently produce documents of high quality.
• Demonstrates attention to details and pro-activity.
• Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
• A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
• Ability to efficiently manage time spent on tasks and proactively identify deficiency. 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.
• Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
• Understands and satisfies client needs.
• Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
• Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.
• Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
• Extensive clinical/scientific writing skills.
• Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
• 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).
• Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
• If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.
• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
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