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Title - Sr. Medical Writer
Location - Pleasanton CA
Duration - 12+ Months
The Medical Writer is an integral member of the Medical Writing team that oversees delivery and execution of the following documents:
Clinical Study Documents
Clinical Validation Plans
Clinical Study Reports
Instructions for Use and/or Package Inserts
This team will be led by a Medical Writing Manager that will supervise one or more Senior Medical Writers as well as an externally contracted team of medical writers. This team will also be part of a larger collaborative working group of Medical Writers from other parts of the organization to share best practices, harmonize documentation, and provide mentorship. Particular scientific focus areas within molecular diagnostics will be Infectious Diseases, Blood Screening, Oncology and Sequencing.
The primary focus of the Senior Medical Writer will be on the generation of new scientific content and on the high quality, properly formatted and timely delivery of 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.
Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs), comments resolution, attention to detail, quality control, accountability, and strict adherence to SOPs and submission-specific requirements. The Senior Medical Writer will be working closely with both internal (e.g., Medical and Scientific Affairs, Biostatistics, R&D, Publications Project Manager, Regulatory, Biostatistics Clinical Operations, etc.) and external SMEs (e.g., customers, KOLs, etc.) that share the responsibility for generating, changing and/or updating scientific content. The Senior Medical Writer will serve as the primary point of contact for most documents.
For selected and high priority documents, oversees and manages 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.)
Responsible for the on-time, properly formatted and high quality delivery of clinical study and scientific communications in accordance with all relevant SOPs/procedures, regulatory requirements, journal/conference submission requirements and quality control systems/procedures.
Conducts literature reviews, perform reference searches, and produces initial drafts of abstracts, posters, manuscript introductions, and/or publications alerts with minimal guidance/direction.
Partners with internal and external SMEs and coordinates cross-functional collaborations/meetings to ensure completeness/accuracy in documentation and meet the defined quality, content and timelines.
Develops scientific posters (using applications such as Microsoft PowerPoint), including the printing and delivery of posters for scientific presentations, in partnership with internal/ external SMEs (see above)
Monitors quality of assigned work and performs consistent, frequent and through quality control checks.
Serves as the primary contact for assigned work and is accountable for ensuring successful completion, including an obligation to report any concerns or completion risks to the Medical Writing Manager or Publications Manager.
Assists Medical Writing Manager with process improvement activities, such as updating SOPs, optimizing document templates, updating publishing standards to support department document workflow, improving quality control (QC), developing technical solutions or monitoring document quality, etc.
Effectively communicates and builds healthy working relationships with other Medical Writing team members and SMEs 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 to Medical Writing Manager.
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.
Master’s degree in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields
English proficiency (both spoken and written)
Doctoral degree (e.g., PhD, PharmD, DVM) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields
English as a primary language
>3 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.
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).
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 drug development (e.g., pharmacokinetics, biostatistics, nonclinical and clinical research)
Knowledge, Skills, and Abilities:
Knowledge and understanding of the clinical research process, including ICH GCP and FDA regulations
Knowledge on Good Publication Practices
Experience in working with Templates, Style Guides, SharePoint and Document Management Tools
Computer skills/expertise in Microsoft Word/ Powerpoint/ Excel and Adobe Acrobat/ PDF software
Calendar management skills/ expertise using Google Calendar
Reference management skills/ expertise with EndNote (preferred) or equivalent
Six Sigma training (preferred, not required)
Meticulous attention to detail
Strong interpersonal and communication skills, including conflict resolution and influencing
Comfortable with virtual work environments and meetings
Ability to work effectively in a fast-paced environment and with multiple high priority projects
Ability to problem solve and delegate appropriate tasks to collaborators and follow-up as needed to meet
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