Senior Medical Writer
United States of America, Remote Job ID R0000030034 Category Medical Writing Date Posted 12/12/2024Overview
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
Parexel has an exciting opportunity for a Senior Medical Writer!
The Senior Medical Writer will independently research, create, and edit regulatory documents of varied complexity associated with clinical research. Project leadership experience required: primary client contact for medical writing deliverables, collaboration with Parexel or client stakeholders to plan and meet deliverable timelines and expectations in terms of process, content, quality, and team management.
Skills
- Excellent interpersonal, verbal, and written communication skills.
- Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. Efficiently manages time spent on tasks and proactively identifies deficiency.
- A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
- Competent in a matrix environment, values teamwork and understands roles of other project team members. Proven team leadership skills and cross-cultural sensitivity.
- Exhibits sound judgement by presenting solutions or escalating issues to project teams or departmental management as appropriate. Follows through to ensure problems have been satisfactorily resolved.
- Strives to understand and satisfy client needs. Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
- 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. Provides Parexel colleagues with pertinent information to formalize a sound business strategy.
Knowledge and Experience:
- Extensive clinical/scientific writing skills and demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
- Ability and willingness to work in a fast-paced, rapidly changing environment.
- Scientific background; 3- 7 years of writing experience includes multiple clinical documents: study reports, study protocols, CTD documents or similar.
- Advanced MS Office skills (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).
Education:
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
#LI-REMOTE
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
Employee Insights
TEAM IMPRESSIONS
WHY MEDICAL WRITERS WORK AT PAREXEL
