ExecuPharm FSP - Senior Medical Writer

Parexel International Corporation

USA - Any Region - Home Based


Job Title: ExecuPharm FSP - Senior Medical Writer

Position Purpose:

The Senior Medical Writer will support clinical study reports (CSRs), including narratives, study protocols and protocol amendments, common technical document (CTD) sections (e.g., Modules 2.5 and 2.7) and other documents for submission to regulatory authorities for sponsored studies.

Organizational Relationships:

• Reports to an assigned ExecuPharm (EP) Line Manager, with day-to-day direction from sponsor Line Manager

• Interacts with study team members and cross functional strategic teams as required.

Primary Duties:

• Write/edit CSR, including narratives, study protocols and protocol amendments, CTD sections (e.g., Modules 2.5 and 2.7) and other documents for submission to regulatory authorities

• Develop and manage timelines for document development

• Circulate documents for team review and quality control (QC) and manages team feedback

• Represent medical writing on study teams and cross-functional strategic teams

• Work on problems of diverse scope where decisions are based upon a mixture of analysis, wisdom, experience, judgment, and rigorous logic and methods

• Acts independently to determine methods and procedures on new assignments

• Complete training assigned by sponsor and/or EP, as necessary, including general training requirements, SOPs and system and process-related training

• Adhere to EP and Sponsor SOPs and processes

• Occasional travel to Sponsor’s office for document discussion meetingsQualificationsSkills and Education:

• BA/BS in life sciences required, but advanced degree preferred

• A minimum of 5 years’ experience in clinical regulatory medical writing required

• Solid understanding of Food and Drug Administration/International Conference on Harmonisation guidelines and Good Clinical Practices

• Expert abilities in Microsoft Word, Excel and PowerPoint

• Experience with Adobe Acrobat

• Strong written and verbal communication skills

• Demonstrated leadership skills

• Ability to coordinate and prioritize multiple projects in a fast-paced environment

• Ability to anticipate and address issues with potential to impact timelinesEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


2021-03-26 01:00:44


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