The Senior Medical Writer is an integral member of the Roche Molecular Systems (RMS) Medical Writing team whose primary focus includes technical writing support for the following Clincal Study documents:
Clinical Validation Plans
Intended Use Statements
Clinical Study Reports
Instructions for Use and/or Package Inserts
Medical Opinion Document
In addition, this position would be expected to work with Medical Affairs to offer technical writing support for the following scientific communications:
This position reports to the RMS Medical Writing Manager. Scientific focus areas for the group include Infectious Diseases and Oncology. Technological focus areas include PCR and Sequencing.
Partners closely with subject matter experts (SMEs) from different clinical disciplines to take the existing product portfolio with associated clinical regulatory documents and ensure their compliance with new regulations from the European Union (e.g. In Vitro Diagnostic Regulation).
Conducts literature reviews, performs reference searches, cohesively collates relevant clinical and scientific information from different sources, creates new scientific content, and produces initial drafts of Clinical Study Documents and/or Scientific Communications with minimal guidance/direction.
For selected and high priority documents, oversees and manages the entire document lifecycle; serves as primary contact for assigned work, and ensures the timely delivery of high quality documents in accordance with all relevant RMS SOPs/procedures, regulatory requirements, quality control systems/procedures, and journal requirements for scientific publications. This position would participate in kickoff meetings to define assignment scope with key stakeholders (content, quality and timelines), document template/shell creation, authoring either independently or collaboratively, internal review processes (iterative QC checks, version control, team review and comments resolution), finalization and approvals.
Activities for Scientific Communications, if any, will be done in close coordination with the RMS Scientific Communications Project Manager and responsibilities may include interfacing with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, and electronic consolidation of submission documents.
Supports development of scientific posters including the printing and delivery for scientific presentations, in partnership with the Medical Writing team and/or other internal/ external SMEs
Interfaces closely with RMS Medical Writing Manager to transparently communicate any project-related concerns or work absences, communicate Medical Writing best practices, and assist with process improvement activities, such as updating RMS SOPs, optimizing document templates, managing collaborative work tools, improving quality control, exploring automation opportunities, managing reference libraries etc.
Responsible for proactive timeline management, project and process management, cross-functional meeting coordination, effective communication, building healthy relationships with team members, active participation in team meetings, demonstrating great attention to detail and being highly organized, and simultaneously managing and driving several projects to completion
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.
Acts as a mentor to less experienced members of the Medical Writing team; is committed to others and own professional development; and exhibits skills of agility, effective decision-making, adaptability to change and influencing without authority.
The Essential Responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. This position may be required to perform additional duties as required.
Doctoral degree (e.g., PhD, PharmD etc) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, or other related/ relevant fields
English as a primary language
3 years scientific research and/or medical writing experience in academic settings or pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports.
Understanding of regulatory and audit requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to the U.S. Food and Drug Administration (FDA).
Excellent project management skills and ability to drive several high-impact projects simultaneously
Submission and publication management of scientific manuscripts to at least 5 different journals
5 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports.
Supervisory and/or project management experience
Submission and publication management of scientific manuscripts to at least 10 different journals
Experience with in vitro diagnostics, molecular diagnostics and/or Infectious Disease
Knowledge of different aspects of assay development (e.g., biostatistics, nonclinical and clinical research)
On-site presence required with minimal travel requirements
Occasional domestic travel to select conferences or internal meetings.