What are the responsibilities and job description for the Senior Medical Editor - WFH position at McKesson Corporation?
It's More Than a Career, It's a Mission.
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
Our Senior Medical Editor works closely and effectively with SCRI Medical Writers (MWs), Medical Editors (MEs), and Medical Writer Managers, as well as other departments, for the timely delivery of high-quality documents. You are responsible for proofreading, editing, formatting, and occasionally publishing various clinical and regulatory documents. You will assist the MW Manager in the development and maintenance of internal MW style guidelines, departmental policies, and quality check (QC) procedures, and provides leadership, strategy, training, and mentoring for the MEs.
Duties include and are not limited to:
- Expert editorial review of various types of clinical/regulatory documents (including but not limited to: clinical study reports [CSRs], protocols, informed consent forms, manuscripts, abstracts, posters, Investigator's brochures, and other regulatory documents) for grammar/formatting; internal consistency between text, data, and tables; alignment with source documents and editorial changes and comments; and adherence to SCRI and/or Sponsor style guides. Available for final read-through of documents leaving the department (high-level template and style and/or thorough copyediting) as necessary
- Preparing documents (formatting, bookmarking, hyperlinking, creating tables of contents, etc.) for adhering to regulatory and sponsor-specific requirements for electronic publishing and submission to regulatory agencies; serving as department subject-matter expert on electronic publishing and submission-ready standards
- Writing patient safety narratives and preparing administrative and data appendices for CSRs, working with other DI departments to gather documents and information, and formatting all CSR documents for publishing per FDA and International Council for Harmonisation (ICH) guidelines and sponsor-specific standards; working with DI and sponsor stakeholders to develop and align best practices
- Staying aware of updates to regulatory guidelines and industry initiatives and sharing these issues with the team as appropriate
- Managing and following MW department styles and approved formats, templates, and guidelines for documentation in order to maintain consistency and high quality; creating or contributing to new or updated guidelines, processes, standards, and QC checklists as needed
Qualifications
- Bachelor's Degree required, Master's Degree preferred
- 3 relevant editing or writing experience in any field (3-5 years) or a 4-year degree in a discipline that provides significant writing skills and experience
- 3 years preparation of professional documents and/or research publications
- Expert understanding of Good Clinical Practices (GCP), FDA and ICH guidelines, local regulations, as well as global industry standards
Preferred experience
- 3 - 5 years' work experience preparing regulatory documents and processes, especially providing electronic deliverables
- BELS Certification (ELS)
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the world's leading oncology research organizations conducting community-based clinical trials. In 2022, SCRI formed a joint venture with former US Oncology Research to enhance clinical trial access and availability across the country. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 600 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. The combined research network brings together physicians who are actively accruing patients to clinical trials at more than 250 locations in 26 states across the US. Please to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please .
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
McKesson is an equal opportunity and affirmative action employer - minorities/females/veterans/persons with disabilities.
