Sr. Medical Writer Job in Telecommute

Status: Permanent
Location: Homebased (US residents)
Ideally, we would like to focus on someone that has both regulatory and commercial document experience.

Sr. Medical Writing Specialist

 

Purpose of Job:

Senior Medical Writing Specialist is responsible for developing, writing, and editing clinical

documents for use in regulatory activities. The Senior Medical Writing Specialist will function

independently in carrying out assigned job components.

 

Job Components / Major Responsibilities:

·        This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in consultation with the Manager and Associate Director, Medical Writing and Scientific Communications. All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

·        Develops clinical regulatory documents, including study reports, protocols, and investigator brochures.

·        Develops tables, charts, figures, and other display elements for clinical data.

·        Responsible for complying with client or i3 Statprobe procedures for completing deliverables, obtaining reviews, incorporating edits, and working with teams to complete/finalize deliverables.

·        Manages medical writing activities associated with individual studies, coordinates medical writing activities within and across departments, keeps management and team members informed of project status, actively participates in team meetings; leads meetings as required.

·        Thorough knowledge of drug development process and regulatory guidelines.

·        Responsible for continuing professional development to keep pace with regulatory guidances and client expectations. Affiliates with professional organizations and participates in continuing education programs, conferences, seminars, and workshops, as circumstances permit.

·        Stays aware of the budget specifications for all assigned projects, working within the budgeted hours and communicating any changes to specifications to the Manager, MWSC or Project Manager, as appropriate.

·        Completes all administrative tasks within specified timeframes.

·        Develops good working relationships with internal and external colleagues.

 

Qualifications:

·        Bachelor’s degree in life science or clinical field of study required; MS, MPH, PharmD, PhD, or other advanced life science degree preferred.

·        Extensive experience in writing clinical regulatory documents in a pharmaceutical, CRO, or freelance environment.

·        Knowledgeable of eCTD organization and preparation.

·        Thorough knowledge of relevant GCP, ICH, and FDA guidance documents.

·        Detail oriented.

·        Excellent proofreading, editing, and internet research skills.

·        Proficient in the use of English grammar, punctuation, and spelling.

·        Working knowledge of basic statistics with ability to analyze descriptive and numeric data and present these with clarity and accuracy.

·        Thorough knowledge of clinical research design and methodology.

·        Excellent organizational and planning skills.

·        Proficient in the use of Microsoft Office software. Proficient in the use of customized Word functionalities, including Documentum, templates, style guides, table formatting, and customized toolbars.

·        Has good interpersonal skills; enjoys team collaboration.