Senior Principal or Principal Medical Writer

Newton , MA

Posted: 06/26/2019 Employment Type: Contract Industry: Life Sciences Job Number: 229794

 
Senior Principal or Principal Medical Writer 
Contract
6 Months
Part-time hours to ramp up to full-time hours. 

Desired Skill:
•  ability to work in a fast paced, ever changing environment

The Senior Principal or Principal Medical Writer reports to the Senior Director of Medical Writing and provides medical writing support in an independent manner. The Senior Principal or Principal Medical Writer serves as a mentor to junior medical writers.

RESPONSIBILITIES:
• Lead and manage medical writing projects including the design, planning, and preparation of clinical and regulatory documents (including protocols, amendments, Investigator Brochures, clinical study reports, briefing documents, Module 2 summary documents). 
• Provide strategic guidance to teams regarding the flow of content and guidance(s) pertinent to the above mentioned clinical and regulatory documents.
• Manage the review and approval of documents.
• Provide leadership for medical writing processes, standards, and innovative initiatives.
• Contribute to generation and maintenance of templates and standard text for clinical documents.
• Provide training and guidance to other medical writers, including scientific and operational mentorship and coaching in the design, planning, and execution of their assignments.

QUALIFICATIONS:
• More than 8 years (10 years for Senior Principal level) of Medical Writing experience with evidence of increasing responsibility/technical development.
• B.S. or equivalent degree in a scientific area.  Advanced degree (MS or PhD) preferred.
• Knowledge of regulations relevant to medical writing.
• Ability to manage multiple documents simultaneously.
• High degree of attention to detail.
• Ability to work with cross-functional teams to complete documents based on predefined timelines.

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