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Senior Medical Writer
Ref No.: 18-13474
Location: Frazer, Pennsylvania
Start Date: 10/10/2018

Senior Medical Writer

Position Summary:

A Senior Medical Writer, in Global Regulatory Medical Writing, provides intermediate medical writing support to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation in support of drug development, product registrations, and product marketing.

Essential Functions:

· Writes and/or edits clinical regulatory documents (generally clinical study protocols/amendments, clinical study reports, and Investigator's Brochures and briefing documents)
· Preferably demonstrated experience with Clinical Pharmacology documentation and early clinical phase summary documents.
· Ensures that these documents are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
· Prepares other documents for regulatory submissions
· Advises Clinical (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays.
· Ensures quality assurance of own documents
· Provides leadership/strategy at the cross-functional study-team level for individual documents
· Participates significantly in meetings at the document-team level
· Contributes to the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
· Works successfully in a cross-functional global team
· Communicates information clearly and concisely


· PhD/PharmD in life sciences (or other related field) with a minimum of 2 years of experience related to medical writing, Masters in life sciences (or other related field) with a minimum of 3 years of experience or Bachelor's degree with a minimum of 5 years of experience. Preferably education in Pharmacology or Pharmacy.
· Excellent English, both written and spoken.
· Intermediate writing and editing skills and competence in the use of relevant software applications, and using templates, and other electronic formats
· Intermediate knowledge of government regulations pertaining to drug development and understanding of the Company's products and standard operating procedures (SOPs)
· Ability to organize and present information and to communicate regulatory medical writing processes and technical and editorial standards
· Good organizational/planning and problem-solving skills at the document level
· Excellent presentation and written communication skills
· Works successfully with an intermittent level of direct supervision