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Medical Writer II
PAREXEL International Corporation
Own the challenges that lead to innovation and growth
Promoted to Head of Biotech Operations for Americas East, helping clients develop novel therapies with a focus on patient needs.
Advanced to Corporate VP Clinical Operations to lead Site Monitoring for Americas, Europe and SE Asia.
Streamlined Parexel’s clinical operations model; driving effectiveness, and increasing employee, client and site satisfaction.
Promoted to VP Clinical Operations, and relocated to the US in 2017.
Promoted to Senior Director of Clinical Operations for the Americas, consolidating both North and South American regions.
Joined Parexel as Director of Global Monitoring Operations for Latin America.
Create the solutions that drive global projects to success
Promoted to Senior Director, Project Management. Taking on management responsibilities for dedicated Enterprise accounts and enhancing his contributions to Parexel’s Global Project Leadership.
Managing Project Director role for dual Enterprise accounts, with a focus on client delivery and satisfaction in order to bring in new awards and expand growth.
Assumed the role of Global Project Leadership Training Coordinator, ensuring new PLs are properly inducted in all regions, while leading cross regional meetings to review and update training materials for PLs.
Promoted to Associate Director in Project Management at Parexel working on post-approval smoking cessation treatment.
Joined Parexel as a Senior Project Lead mentoring and managing 5 project managers working on a phase IV smoking cessation treatment.
Be part of a diverse team that drives healthcare innovation
Advanced into Senior Manager, Human Resources
Promoted to Manager, Human Resources Operations
Joined Parexel as a Human Resources Operations Partner.
Human Resources Business Partner at leading pharmaceutical company.
Manager of Diversity Resources.
Contribute to meaningful advances that benefit patients in need
Joined the Scientific Data Organization as Scientific Data Technology Director, creating agile access to real world data, bringing best in class technology solutions to Parexel services, and harnessing data to transform therapy development for patients.
Promoted to Director IT Project and Programme Office, leading engineering projects for Wearable and Sensor devices with a view to streamlining Clinical Trials patient engagement and approaches.
Promoted to Associate Director of IT Program and Project Management at Parexel.
Joined Parexel as a Project Manager in the IT Project Program Office.
Own the challenges that make you grow
Promoted to Senior Medical Writer, focusing on the development and support of clinical documents intended for regulatory submission.
Began a new role working remotely as a Medical Writer II, researching and coordinating the development of clinical documents intended for submission to the FDA or other regulatory authorities.
Director of Imaging Operations leading a team of 13 Project Managers and the imaging of over 130 clinical trials.
Senior Project Manager, overseeing standardization of program operations and deliverables while leading a team of Project and Imaging Research Managers.
Promoted to Project Manager for clinical oncology trials.
Joined Parexel as an Imaging Research Associate on clinical trials utilizing medical imaging.
Forge the relationships that elevate customer experience
Corporate Vice President, General Manager – Japan
Vice President, Growth Accounts
Senior Director of Business Development at Parexel.
Associate in the Proposal Development department at Parexel.
One of the founders and Marketing Director of an IT venture company developing web related systems
Voice the ideas that get treatments to patients faster
Promoted to Senior Director of Clinical Application Development and Technology.
Promoted to Associate Director of IT.
Promoted to Senior Programmer.
Joined Parexel in Clinical IT.
Received Master's in Computer Applications.
Own the challenges, program your future
Promoted to Senior Manager, Statistical Programming, with increasing responsibilities for department development and team supervision.
Advanced to Statistical Programming Manager, responsible for a dynamic, multinational team of over 12 people.
Increased responsibility, leading projects and managing small teams as a Principal Statistical Programmer / Associate Manager.
Promoted to Senior Statistical Programmer, participating in high profile trials for diverse range of sponsors, as main programmer.
Referred by a friend to join Parexel as a Statistical Programmer, taking the opportunity to further develop my programming skills in 4GL language using SAS® .
Natalia – Head of Biotech Operations for Americas East
Ruben – Senior Director
Deborah – Senior Manager
Scientific Data Technology Director
Nicholas – Senior Medical Writer
Shigehiro – Corporate Vice President, General Manager – Japan
Naresh – Senior Director of Clinical Application Development
Pawel – Senior Manager
Medical Writer II
USA - Any Region - Home Based
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.
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,
knowledgeable, and it is easy to communicate with other staff."
Christine, Medical Writer II
"Parexel makes it easy to communicate and interact with each other, which allows
me access to expertise and knowledge beyond my own."
Kristy, Associate Manager
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.
Parexel is one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We are currently looking for:
As a Parexel Medical Writer II you will be exposed to different project teams, therapies and devices, as well as a diverse portfolio of clients. The ability to understand our clients’ needs and achieve quality results is critical for us to continue to be one of the best clinical research organizations (CROs) in the world. To accomplish this, we believe that you must have the ability to work independently as well as collaboratively every day.
Our writers are an integral part of clinical teams that support our clients worldwide and they assist those teams in writing and coordinating successful documentation across a wide range of therapeutic areas. Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as the primary client contact.
Excellent interpersonal, verbal, and written communication skills.
Ability to consistently produce documents of high quality.
Demonstrates attention to details and proactivity.
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.
Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members. Possesses team leadership skills and cross-cultural sensitivity.
Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
Strives to understand and satisfy 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.
Knowledge and Experience:
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 study reports.
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.
Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
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.
FAQ: Hiring during COVID-19
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Meet Julia: Medical Writing
Julia provides leadership insights, inspiration and advice from her 20 years at Parexel.
'Corporate Equality Index' 2021
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