Medical Writer II

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Key Accountabilities:

Author Clinical Documents

• Gather review analyze and evaluate pertinent resources to prepare develop and finalize clinical documents for submission to regulatory authorities including but not limited to: model informed consents interim and final clinical study reports and safety update reports.

• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.

• Follow required standard operating procedures (SOPs) templates guidelines regulations client instructions and other processes as applicable.

• 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 appropriateness of content/format for clinical writing.

Quality Control

• Ensure that all work is complete and of high quality prior to team distribution or shipment to client:

• Confirm data consistency and integrity across the document.

• Prepare documents for publishing readiness when applicable

• 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.

• 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.

Document Project Management

• Serve as primary client contact for medical writing projects negotiating deliverable timelines and resolving project-related issues.

• Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership with departmental supervision: 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.

• 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.

• Attend or lead project team meetings as required. With departmental supervision mediate conflict or 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.

• Supervise collection of documentation by Medical Writing Support Coordinator 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.

• Develop collaborative relationships with teams/clients for a productive and professional working relationship.

• Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.

Training/ Compliance

• Attend and complete mandatory corporate project-specific and departmental training as required.

• Keep abreast of professional information and technology through workshops and conferences (when approved) and assure appropriate transfer of that information to the department

• Provide guidance to new staff as well as less experienced departmental members

General

• Attend departmental and company meetings as necessary.

• Comply with departmental procedures and requirements such as completion of project assignment and workload trackers on the applicable software platform.

• May participate in departmental or interdepartmental process improvement and training initiatives including development of departmental SOPs templates and general guidelines for clinical documentation and workflow procedures

Skills:

• 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 ones 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.

• If required to perform translation work and quality control of documents written in non-English language proficiency in relevant language is a prerequisite.

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Education:

• Bachelors degree in Life Sciences/Health Related Sciences or equivalent.

Employment Type : Full-Time
Experience: years
Vacancy: 1