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The Medical Writer Manager oversees a team that delivers and executes the following documents:
Clinical Study Documents
Clinical Validation Plans
Clinical Study Reports
Instructions for Use and/or Package Inserts
The primary product focus is on molecular diagnostics in the areas of Infectious Diseases, Blood Screening, Oncology and Sequencing. The team is comprised of RMS Senior Medical Writer(s) and an external vendor team of Medical Writers. The RMS Senior Medical Writer(s) will focus on the generation of new scientific content and on selected high priority Clinical Study Documents and Scientific Communications. The Senior Medical Writer will conduct literature reviews, perform reference searches, and produce initial drafts of abstracts, posters, manuscript introductions, and/or publications alerts. The team of externally contracted Medical Writers (using a single vendor) will be to provide support on Clinical Study documents for regulatory submission (majority of contributions) and Scientific Communications for publication submission and/or presentation.
Overall, the Medical Writing Manager will be accountable for the high quality, properly formatted and timely delivery of documents. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs to provide content), comments resolution, attention to detail, quality control, accountability, and strict adherence to RMS SOPs, regulatory requirements and submission-specific requirements. Medical Writers will work closely with internal project-level SMEs (e.g., Medical and Scientific Affairs, Clinical Operations, Regulatory Affairs, Biostatistics, R&D, etc.) and external SMEs (e.g., customers, KOLs, etc.) that are responsible for generating, changing and/or updating scientific content.
Accountable for and manages day-to-day activities of the Medical Writing team, such as assignment delegation, performance reviews, professional development/coaching, budgeting and time-tracking, process improvement, document standardization and KPI reporting/tracking.
Independently leads process improvement initiatives, such as updating RMS SOPs, optimizing document templates, updating publishing standards to support department document workflow, improving quality control (QC), developing technical solutions or monitoring document quality, etc.
Periodically communicates team activities, progress, and goals to leadership through one-on-one (e.g., in-person meetings, emails) and group communications (e.g., PowerPoint presentations)
For selected and high priority medical documents, will serve as primary point of contact with oversight and management responsibility for the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals), and submission (interface with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, electronic consolidation of submission documents, etc.)
Partners with the RMS Publications Manager to assign (to the Medical Writing team) and complete selected Scientific Communications.
Collaborates with other Medical Writing teams within Roche to share best practices, harmonize documents and improve related processes/procedures.
Effectively communicates and builds healthy working relationships with Medical Writing team members and key stakeholders throughout the organization with whom he/she will work closely.
Actively participates in Medical Writing team meetings and activities.
Successfully completes all assigned curricula and on-the-job training modules.
Performs his/her work in accordance with Roche cultural beliefs and agreed upon Key Performance Indicators (KPIs).
Provides appropriate and transparent notification for work absences.
The Essential Responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. Incumbents may be required to perform other duties as required.
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