Senior Medical Writer

The Senior Medical Writer is responsible for gathering and synthesizing information for the purpose of providing high quality documents to support the execution and reporting of sponsors' research programs.

Job Type: contract
Job Category: Medical Writing
Region: USA
Location: Remote
Posted: 1st July 2020
Ref: AS001

Primary Responsibilities:

The Senior Medical Writer is responsible for gathering and synthesizing information for the purpose of providing high‑quality documents to support the execution and reporting of sponsors’ research programs.

Tasks Performed:

  • Serve as the Medical Writing representative on assigned project teams.
  • Develop clinical protocols for clinical studies of any complexity.
  • Review and provide feedback on client-provided protocols, as required.
  • Contribute to risk assessment and management plans (RAMPs) for assigned studies.
  • Review case report forms (CRFs) and statistical analysis plans (SAPs), as required, to ensure completeness and accuracy of clinical data collection and presentation for final analyses.
  • Create clinical study reports (CSRs), standalone safety narratives, and integrated safety summaries for studies of any complexity and incorporate results and feedback from other departments assuring compliance with regulations, standard operating procedures (SOPs), Good Clinical Practice (GCP), and client expectations.
  • Analyze and interpret clinical and safety results for studies of any complexity including vital signs, clinical laboratory values, adverse events (AEs), electrocardiograms (ECGs), diagnostic procedures, etc.
  • Confirm accurate classification of events and medications using standardized coding systems.
  • Prepare and review CSR appendices in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.
  • Review and provide assistance on answering deficiency letters from regulatory agencies, as required.
  • Perform literature searches/reviews as necessary to obtain background information for development of documents.
  • Coordinate internal review and manage incorporation of external feedback for protocol and CSR documents assuring feedback is appropriately addressed.
  • Perform quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
  • Actively participate in internal and external project team meetings, as required.
  • Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.
  • Conduct all work in compliance with SOPs, GCP, and all regulatory guidelines.
  • Maintain familiarity with client expectations and produce documents consistent with these.
  • Maintain thorough understanding of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as ICH and GCP procedures.
  • Participate in departmental or interdepartmental quality improvement initiatives.
  • Support training of Medical Writers and Medical Writing Associates.
  • Assist in coordination of team workload.
  • Maintain and participate in the objectives of the department.

 

Qualifications:

  • Excellent verbal and written communication skills.
  • Ability to acquire and apply knowledge quickly.
  • Professional attitude and strong interpersonal skills.
  • Ability to work well with a multi-disciplinary team of professionals.
  • Client-focused approach to work.
  • Flexible attitude with respect to work assignments and new learning.
  • Ability to prioritize workload.
  • Superior attention to detail.
  • Understanding of clinical research, drug development process, and applicable regulatory guidelines.

 

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