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Sr. Medical Writer

Cambridge, MA 02142

Post Date: 06/15/2018 Job ID: 1988 Job Category: Clinical: Medical Writing

As an integral part of the clinical team, the Senior Medical Writer independently develops and delivers high quality, strategically aligned clinical and regulatory documents. The Senior Medical Writer is responsible for ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. The Senior Medical Writer must be able to work effectively in a team environment and must have strong scientific, interpretive, organizational, and project management skills.

Primary Responsibilities Include:
  • Plan, prepare, write, edit, format, and finalize clinical and regulatory documents. Documents will include, but are not limited to: clinical protocols, clinical study reports, Investigator’ s brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, risk management plans, and regulatory responses.
  • Coordinate the internal review and approval of documents.
  • Effectively collaborate with Clinical Research and Development colleagues, along with other  departments including, but not limited to, regulatory, safety, biostatistics, clinical operations, medical affairs, and the commercial group.
  • Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
  • Coordinate deliverable with external vendors.
  • To ensure compliance, remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature.

  • Excellent writing skills
  • Minimum of a Bachelor’ s degree with 8 to 10+ years of industry experience as Medical Writer
  • Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by a cross-functional team
  • Knowledge of current regulatory requirements and guidelines applicable to GCP/ICH/eCTD compliant documents
  • Previous experience with NDAs/MAAs with active contribution in planning, preparation, and writing of clinical and regulatory documents
  • Ability to multitask, deal with competing priorities, and meet aggressive timeline expectations
  • Experience in working with cross-functional teams
  • Excellent interpersonal and communication skills
  • Flexibility/adaptability to work in a fast-paced and dynamic environment


Dorie McCrann
Senior Clinical Recruiter

Dorie is a great listener who connects easily with candidates and clients. She brings 18 years of full life-cycle recruiting experience to The Steely Group, and attributes her success to a customer-focused approach, attentive communication, and strong networking skills.

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