Senior Principal Medical Writer (Remote)
REMOTE, IL 00000 US
Serves as medical writing lead on the most complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers exhibiting the highest level of team management. Leads clinical documents and document teams for regulatory submissions. Provides direction, guidance, and mentoring to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers regarding work
Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US). Coaches, mentors, and assists medical writers. May provide guidance to external vendors
Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to scientific publishing projects.
Knowledgeable about the product/disease state and is an expert on clinical documents. Continually trains/is compliant with all current industry requirements as they relate to clinical regulatory submissions.
Responsible for effective communication to team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals
Understands, assimilates, and interprets sources of info. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
Provides project management for writing projects for multiple compounds and/or indications within assigned therapeutic area, including submissions, ensuring accuracy and adherence to timelines and processes. As assigned, mentors and provides guidance to medical writers. Oversees writing projects to ensure timeline completion. Must resolve conflicts, remove barriers, and generate innovative ways to ensure teams achieve project goals.
Works directly with team members to develop/implement timelines to meet desired project completion dates. Coordinates activities and communications with functional areas such as Statistics, Regulatory, Submission Operations, Pharmacokinetics, Medical Directors, Safety Team on writing projects/submissions. Effectively collaborates with clinicians and management utilizing cross-functional skills/expertise and drug development knowledge.
Arranges and conducts review meetings with the team. Acts as interface to resolve issues and questions arising during the writing process. Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary. Recommends, leads, and implements tactical process improvements within the department. Leads departmental initiatives.
Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve.
Ability to lead productive cross-functional working teams, including addressing issues that arise. Collaborative teamwork and leadership track record. Excellent business communication skills with aptitude for summarization as well as detail orientation.
Bachelor's degree in English or Communications with relevant science expertise or Bachelor's degree in Life Science with relevant writing expertise. Advanced degree and/or professional certification/credentials preferred. Demonstrated leadership and proficiency in or willingness to learn required systems.
4+ years relevant industry experience in medical writing or a related area such as quality, regulatory, clinical research, or product support; 2 years in a project management role required
American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
Demonstrated experience writing complex documents and demonstration of superior team management. Experience in working with collaborative, cross-functional teams, including project management experience.
Ability to understand and interpret medical data and create and develop strategic messaging required.
Microsoft Office and Internet navigation proficiencies essential. Working knowledge of statistical concepts and techniques required. Working knowledge of other business-related information technology. Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.
Identify and employ rigorous logic and methods to independently and effectively solve difficult problems within and outside routine work situations. Recognize potential scheduling and resource conflicts for project and provide recommendations to resolve. Probe multiple sources for answers. Identify hidden issues and problems beyond the obvious. Appropriately identify when to independently address the situation and when to elevate the issue to management and/or development team(s) for resolution.
Primary Location USA-United States of America
Travel Yes, 10 % of the Time
Organization Research & Development
*CO/NYC candidates may not be considered
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