Senior Medical Writer

Responsibilities

• Mentor and train junior medical writers and/or external contractors
• Work with the sponsor’s and/or PROMETRIKA’s medical personnel and statisticians to develop/write clinical development plans, clinical study protocols, clinical study reports, and other documents, as appropriate
• Create template/shell for integrated clinical study report based on ICH guidelines and sponsor’s standards and in accordance with the study protocol
• Hold review meetings to discuss edits provided by the PROMETRIKA team and/or the sponsor, as needed
• Write journal articles, abstracts, and posters in cooperation with responsible statisticians and/or the sponsor
• Write clinical sections of INDs, NDAs, and other submission documents
• Prepare annual reports and briefing documents for regulatory submission
• Manage consistency of style, format, and content for all IND and NDA documents within a given project
• Review and provide feedback on medical writing SOPs
• Attend project team and client meetings as required
• Affiliate with contributing materials and presenting at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization
• Affiliate with contributing to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate
• Affiliate with collaborating with Client Relations to participate in Medical Writing at bid defense meetings
• Affiliate with leading Medical Writing departmental initiatives aligned with organizational strategic goals
• Uphold, demonstrate and teach junior team members PROMETRIKA’s Core Competencies
• Affiliate with developing internal training materials and deliver training as in support of PROMETRIKA Technical Training Committee initiatives

Qualifications

• Bachelor’s degree in a scientific discipline is required
• Graduate degree is preferred

Skills

• Knowledge of ICH recommended content of Investigator Brochure, Clinical Study Report, IND, IND updates and NDA
• Knowledge of electronic document platforms is desired
• Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred