- Provides advanced document-level compilation and publishing services for Medical Writing, including clinical study reports (CSRs); protocols and protocol amendments; investigator brochures; annual reports, and other regulatory documents that meet current ICH electronic document requirements and guidelines.
- Interacts with the medical writing department and with project teams within the company (Project Leads, Clinical, Data Management, Regulatory Consulting, Biostatistics), and in some cases direct contact with clients to ensure that all regulatory specified documents are complete, accurate, and compatible with sponsor and regulatory agency software programs.
- Primary responsibility for all components of document compilation and publishing
- Requires good working knowledge of FDA, EU, ICH and ISO guidelines to ensure submission documents meet or exceed sponsor and regulatory requirements and guidance.
- Responsible for the thorough peer review of published documents created within or outside of the Company, when applicable.
- Interacts with medical writers and medical editors in the medical writing department
- Interacts with cross-functional project teams within the Company (Project Leads, Clinical, Data Management, Regulatory Consulting, and Biostatistics), and with clients as applicable.
- Assists in training and mentoring Publisher I staff.
- Performs other work-related duties as assigned.
- Associate’s degree preferred.
- Strong experience in an office environment, with pharmaceutical/medical device or CRO experience preferred.
- Adobe Acrobat Professional and ISI Toolbox experience preferred.
- Strong proficiency in Microsoft Office Suite (Word, Excel) preferred.
- Must have above average attention to detail, editorial and proofreading skills, accuracy, problem-solving and organizational, interpersonal, and team-oriented skills.
- Ability to perform numerous tasks simultaneously without losing sight of overall objectives.
- Ability to work independently as well as part of a team and to keep others informed of the progress and status of writing projects.
- Adaptable to changes in work duties, responsibilities, and requirements.
- Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
FLSA status: Non-exempt
Years of experience required: Minimum of two (2) years of publishing experience and electronis publishing of regulatory documents.
Physical Requirements: Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.
North America – US Home-Based
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