Process Writer, Process and Procedures Documents
United States of America, Remote Job ID R0000033620 Category Medical Writing Date Posted 05/14/2025Overview
As a Medical Writer at Parexel, your strong scientific knowledge, writing skills, and patient focus effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You must be able to collaborate within cross-functional teams to achieve the development of a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.
We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Consistent
- Deadline-oriented
- Detail-oriented
- Insightful
About This Role
The Global Development Process & Procedures (P&P) Process Writer is responsible for project facilitation and creation of Global Development process documents in collaboration with Process Owners and Subject Matter Experts
- Manages and leads projects for the development of procedural documents for global development by:
- Assessing how the creation or update of procedural documents impacts other procedural documents through the management of document Impact Assessments. o Identifying the stakeholders/SMEs and ensures they are engaged in the content development/revision activities, including review and approval cycles.
- Lead the Technical Writing of Global Development procedural documents in collaboration with functional process owner and cross-functional SME(s) by translating complex cross-functional concepts to process maps and documentation ensuring any open process deviations, inspection commitments, corrective/ preventative actions and critical gaps are addressed.
- Facilitate process mapping activities capturing process details (scope, boundaries, inputs, outputs, process steps and sequence) while allowing for the visualization of data flows, identification of bottlenecks and waste, and minimizing redundancies. Identify and evaluate issues and/or gaps in processes and propose effective resolutions.
- Facilitate the adjudication of comments from documentation reviews.
- Collaborate with Quality Managers during content development to ensure alignment with
Content Standards and Lean Writing Principles o Manage document review and approval workflows.
- Maintain project schedule, identifying and mitigating risks or issues, escalating to leadership as applicable.
- Contribute to P&P improvements as applicable.
- Collaborates with Global Development Training, Change Management, and GD Quality when applicable, to support process implementation
- Other duties, as assigned
Bachelor’s Degree - 7+ Years’ Experience
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Potential Career Path
Parexel offers career paths for Medical Writers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Associate Medical Writer
- Medical Writer I
- Medical Writer II
- Senior Medical Writer
- Subject Matter ExpertPeople Management
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WHY MEDICAL WRITERS WORK AT PAREXEL
