Career opportunity as Medical Writer II in Parexel

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PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Post: Medical Writer II

Job Description:
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 updates. 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 primary technical contact with client under appropriate departmental supervision.

Reports To Departmental Line Management, Medical Writing Services
Directly Supervises None
Provides Work Direction to Medical Writer I, Associate Medical Writer, Medical Writing Assistant
Works Closely with Project Managers/Leaders Physicians, Biostatisticians, Data Managers, Regulatory Associates, Medical Writing staff
External Relationships Client technical representatives

Key Accountabilities:
- Write 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 updates.
- Serve as the primary client contact, negotiating deliverable timelines, and resolving project related issues, under departmental supervision. 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, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to PAREXEL guidelines/SOPs including: distribute drafts, chair review meeting, incorporate revisions, document key project events, and complete sign-off procedures.
- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
- Review statistical analysis plans and mock statistical output to determine the appropriateness of content/format for clinical writing.
- Attend internal technical team and client team meetings as required.
- May provide guidance to less experienced departmental members.
- Supervise collection of materials by the Medical Writing Assistant or Associate Medical Writer for assembly of client deliverables and for filing appropriately in project files.
- May participate in departmental or interdepartmental process improvement and training initiatives.
- May participate in development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOPs.
- Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.

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