Gather, review, analyze, and evaluate 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.
to ensure inclusion of all relevant input.
regulations, client instructions and other processes, as applicable.
information and training for development of documents.
appropriateness of content at for clinical writing.
Ensure that all work is complete and of high quality prior to team distribution or
shipment to client.
o Confirm data consistency and integrity across the document.
o Prepare documents for publishing readiness, when applicable.
o Ensure document structure, content, and style adheres to FDA / EMA or other appropriate regulatory guidelines, and comply with departmental,
corporate or client SOPs and style guidelines, as applicable.
o Provide suggested alternative content when contributors provide content
that does not meet document needs.
writers before internal or external distribution. This includes both copyediting and content review.
Act 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.
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 / SOPs.
Distribute final documents to project team and client.
project leader, including changes in project plan, timeline or out of scope
requests, and suggest possible resolution options.
disagreement, as well as timeline delays, among team members by
negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus.
Document Specialist, and / or Associate Medical Writer for assembly of project
files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator.
efficient, productive, and professional working relationship.
Excellent interpersonal, verbal, and written communication skills.
multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g.,
team leadership skills and cross-cultural sensitivity.
business and / or to widen existing scope and services.
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.
reports, study protocols, or CTD documents or similar.
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).
Bachelor's degree in Life Sciences / Health Related Sciences or equivalent
Why Work at PAREXEL
There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.
The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?
A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s Parexel. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.
Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.