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Senior Medical Writing Consultant

Cambridge, Massachusetts

Post Date: 08/14/2017 Job ID: 1581 Job Category: Clinical: Medical Writing

Our client is seeking a Medical Writing Consultant to work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines in order to support drug development under strict timelines.

Job Responsibilities:
  • Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient production and publishing of documents and dossiers.
  • Function as an integral part of the Medical Writing team which includes external vendors.
  • Ensure a consistent style of presentation of documents to maintain quality and ease of review.
  • Perform quality control (QC) review of clinical study reports and other submissions written by other medical writers.
  • Keep management informed on progress documents and other project related information.
  • Assist management in projecting resources, and perform administrative duties as requested.
  • Contribute to the design and maintenance of templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.
  • Represent Medical Writing on cross-functional teams.
  • Collaborate with and support the department leadership to ensure continuous improvement, and high standards for quality and productiveness.

Qualifications/ Requirements:
  • 3+ years as a medical writer, or equivalent, and presenting relevant specialist qualifications;
  • Bachelor’ s degree in a clinical, scientific, or industry-related discipline is strongly encouraged.
  • Experience with NDAs
  • Onsite 2-3 days a week required, live within commutable distance
  • Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired.
  • Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
  • Familiarity with the requirements for preparation of key clinical and regulatory documents

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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