Senior Medical Writer - Contract - Remote Not right for you? We've got others

Salary:
Confidential
Location:
King of Prussia, PA
Posted:
June 18th 2020
Relocation Assistance:
Available
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The Senior Medical Writer provides innovative leadership to the cross-functional clinical program team, and drives the provision of medical writing services to a clinical program. The incumbent is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program.  He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation.  He / she will mitigate risk associated with medical writing and disclosure processes by establishing and maintaining Best Practices and SOPs.  This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role reports to the Director of Medical Writing and Disclosure.  While it is preferable that these positions sit "in house" in our King of Prussia location, we will consider candidates who prefer to work remotely on a regular basis.

Main Responsibilities and Accountabilities:

Leads the Medical Writing and Disclosure contributions to assigned clinical program(s). Responsible for:

Position Qualifications and Experience Requirements:

Education

Post-graduate qualifications (PhD or MD) preferred

Experience

• Bachelor degree, or equivalent, in Science related discipline.
• Post-graduate qualifications desired (PhD or MD preferred).
• 5+ years of medical writing experience within the biopharmaceutical industry or contract research organization.
• Comprehensive understanding of medical writing for clinical development, including the documents required at each stage and their associated regulatory requirements.
• Comprehensive understanding of medical writing processes, standards and issues.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Expert MS Office skills



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