Sr. Medical Writer

Planet Pharma Pleasanton , CA 94588

Posted 2 months ago


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

  • Protocols

  • 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:

  • Scientific Posters

  • Literature Reviews

  • Scientific Manuscripts

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Scientist

Bio-Rad Laboratories

Posted 3 weeks ago

VIEW JOBS 10/30/2020 12:00:00 AM 2021-01-28T00:00 Add to favorites Favorited View favorites The Digital Biology Group is a multidisciplinary team focused on developing innovative products using our core partitioning technology. Our ddPCR and ddSeq systems have enabled scientists around the world to make impactful discoveries in the life sciences and healthcare. Our mission is to continue creating and providing new tools to scientists that will facilitate more discoveries and advances in research. We currently have an opening for a Senior Scientist in the Product Development team, working on single-cell NGS applications. If you're a scientist who relishes the challenge of building new products and thrive in a matrix environment, please send your resume to HR for this job posting. Responsibilities * Conduct key experiments leading to the successful completion of product development phases. * Lead the development of product specifications and quality metrics to deliver optimum product performance. * Drive Verification/Validations testing and report findings. * Train and support transfer/operations teams in preparation for product launches. * Successfully interact and align with various functional roles (including Marketing, Project Managers, Software Engineers, Computational Biologists, Biostatisticians, QA, RA, and Manufacturing) within the Digital Biology Group to drive project to completion. * Mentoring and coaching of junior technical staff. Qualifications * PhD in Molecular Biology, Biochemistry, or Chemistry with 2+ years of industrial experience (or MS/BS with 8+ years of experience) highlighted with successful NPIs. * Track record of design, execution and analysis of experiments on aggressive schedules in a rapidly changing environment. * Direct experience with next generation DNA sequencing and nucleic acid technology relating to PCR, qPCR, and/or digital PCR. * Adept with designing and executing DOEs and use of statistical analysis programs such as JMP or MiniTab. * Skilled at writing clear plans, reports and SOPs. * Direct experience and full knowledge of Product Life Cycles exemplified by product launch while working under ISO 13485 quality standards. * Excellent verbal and written communication skills, logical and analytical thinking, ability to multitask, work independently and on a team, and the ability to learn, troubleshoot, and problem solve are essential. About Bio-Rad: Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives. Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results. EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Bio-Rad Laboratories Pleasanton CA

Sr. Medical Writer

Planet Pharma