Senior Medical Writer

Senior Medical Writer

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

Responsibilities

The Senior Medical Writer position requires writing and editing of clinical and scientific reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Senior Medical Writer will also assist with and contribute to departmental leadership initiatives, training initiatives, business development efforts and organizational thought leadership. The Senior Medical Writer will:

• 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
• Develop/write clinical sections of INDs, NDAs, and other submission documents
• Write investigator brochures
• 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
• Assist with contributing materials and presenting at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization
• Assist with contributing to PROMETRIKA's newsletters, thought leadership blogs, and other publications as appropriate
• Support in collaborating with Client Relations to participate in Medical Writing at bid defense meetings
• Assist with leading Medical Writing departmental initiatives aligned with organizational strategic goals
• Uphold, demonstrate and teach junior team members PROMETRIKA's Core Competencies
• Assist with developing internal training materials and deliver training as in support of PROMETRIKA Technical Training Committee initiatives
• Perform other duties as assigned

Education

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

Experience

• Minimum of 6 years of experience in medical writing with a minimum 4 years regulatory writing in biotechnology/pharmaceutical industry

Skills

• Knowledge of ICH recommended content of Investigator Brochure, Clinical Study Report, IND, IND updates and NDA along with previous involvement in writing at least one NDA or BLA is required.
• 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

Physical Requirements

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.

The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate's work experience, education/training background and parity with current employees in the same or similar positions.