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Type of Job: Direct hire; permanent role
Compensation: Will discuss with each interested party
General Description:
Management of several writers comprising a subdivision of the Medical Writing Department. Reports to Director of Medical Writing. Writes documents associated with clinical trials. Forecasts and fills resource needs for projects under his/her supervision.
Detailed Description and Job Scope:
Supervises Writers and Editors. Reviews work of Medical Writers and/or Editors and assists in their professional development. Models rigorous and disciplined approaches to medical writing. Communicates a philosophy which strikes a proper balance between high production and high quality. Helps writers to utilize their strengths and work around their weaknesses.
Responsible for resource planning and allocation. This includes forecasting of medical writing needs through analysis of clinical development plans, and monitoring of changes in those plans. Identifies time periods when resources will be taxed and makes plans accordingly. Outsources work regularly to ensure that in-house resources are always available for work that can only be done in-house.
Regularly reviews Department's operations and seeks to improve its effectiveness and efficiency. Develops solutions and oversees their application or directs others to this end. Participates in initiatives which seek to improve our processes. Carries out novel or complex assignments.
Plays an important role in cross-functional teams. Must be highly skilled in representing Medical Writing group in the interdepartmental planning of clinical projects, including regulatory submissions. Demonstrates exceptional ability to collaborate.
Responsible for management of medical writing resources for several development projects. Establishes and enforces timelines for multiple projects and writers. Plays a key role in negotiating timelines for primary projects throughout the organization. For projects under the Senior Manager's supervision, responsible for planning and provision of medical writing resources for submission of marketing applications. Collaborates with other departments to construct timelines and guidelines for the review of summary documents.
Reports to Director of Medical Writing and regularly informs him of the status of projects, morale and performance of direct reports, resource gaps which need to be filled, the quality and timeliness of outsourced work, status of collaboration with other departments, and any other issues which need to be addressed. Assists Director in long-term planning.
Qualifications for Job (Knowledge, Skills, Abilities, Effectiveness, Collaboration and Leadership):
Management skills. Actively increases team performance by aligning objectives, promoting a team approach, and addressing concerns or discord. Considers multiple perspectives and helps team members optimize results. Mentors Medical Writers and Editors.
Must show a broad understanding of clinical research processes, and a familiarity with regulatory processes, along with an in-depth knowledge of other clinical functional areas. Strong understanding of other clinical functions is needed to recognize and appreciate how other departments interact with, and are dependent on, Medical Writing.
Demonstrated expertise in clinical research documentation, ICH guidelines, FDA guidances, and GCP. An understanding of company SOPs, including the need for revision. Will serve as a technical expert in processes for the clinical research team. Well-developed communication and negotiation skills in team environments required.
Must have an in-depth expertise in clinical research and medical writing in particular. Acts as an authoritative resource on medical writing and other areas in clinical research. Ability to influence project strategy and document construction. Demonstrated ability to analyze and resolve complex problems.
Proficient in using Microsoft Excel, Project, and PowerPoint.
Requirements for Job (Years of Experience, Education, Certifications):
MS/MPH in Medical or Life Sciences plus 5 years' experience (or equivalent), including medical writing, project management, and/or clinical monitoring, plus at least one year of proven managerial reponsibility supervising writers.
Contact:
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