Regulatory Medical Writer

Morristown - NJ

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Job Description

Job Summary:


It is the Medical Writer's role to oversee all report writing activities for the projects he/she is supporting. The Medical Writer must ensure consistency across documents and improve overall document quality. It is the Medical Writer's responsibility to provide the appropriate background information, guidance, and training to any writer producing documents to support their tasks.

The Medical Writer will prepare and/or review all final documents (i.e., protocols/analysis plans/reports/Investigator Brochures/submission pieces).



Essential Duties and Responsibilities:


·        Build and maintain knowledge base to improve the overall medical content of documents.

·        Write and/or review clinical and non-clinical study reports and regulatory submission documents, including ISE, ISS, Clinical and Non-Clinical section of an NDA, etc.

·        Write and/or review protocols, amendments, review statistical analysis plans. Ensure appropriate incorporation into reports.

·        Drive the clinical study report writing process by conducting or ensuring the following activities have been accomplished:

o     Identify report contributors and their responsibilities.

o     Develop and maintain timelines.

o     Ensure that all possible report activities are completed prior to database lock.

o     Review primary statistical output and participate in results review meetings.

o     Lead discussions on report finalization.

·        Prepare reports, manage review cycles, and incorporate comments as appropriate.

·        Manage compilation of report appendices.

·        Prepare, review and edit publications.



·        Work effectively with other staff members in team situations, as well as external vendors.

·        Other duties as assigned.


Skills & Requirements



·        Ability to think strategically; demonstrated negotiating skills and resourcefulness.

·        Demonstrated ability to manage several projects simultaneously.

·        Strong leadership ability.

·        Thorough understanding of all aspects of ICH-GCP guidelines; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).

·        Analyzed and interpreted complex data from a broad range of scientific disciplines in both clinical and non-clinical therapeutic areas.

·        Knowledge of statistics and their application to the interpretation and presentation of clinical data.

·        Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.

·        Demonstrated strong writing skills as evidenced by good quality writing in publications in peer-reviewed journals.

·        Understanding of documentation requirements related to submission of manuscripts to scientific and medical journals.

·        Ability to mentor and train others.

·        Superior computer skills, including high-level word processing and graphic presentations. Experience with Microsoft Office including PowerPoint required.

·        Ability to read, write, and interpret the English language.

·        Maintains strong attention to detail in high-pressure situations