QC Medical Writer
About The Position
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. This position reports to Executive Director, Medical Writing Oncology and is part of the Medical Writing Function. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of QC Medical Writer. The QC Medical Writer is responsible for performing Quality Control (QC) audits of medical writing deliverables. The QC Medical Writer may also support the Medical Writing team with scheduling and facilitating document reviews, and preparing clinical study documents (eg, clinical study protocols/amendments, sections of clinical study reports, safety narratives) as appropriate.
Requirements
- Minimum 3 years of relevant experience (quality control of clinical/regulatory documents) in biotech or pharmaceutical industry with Bachelor’s Degree or equivalent years of work experience.
- Oncology experience preferred.
- Working knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Experience using document templates and AMA style.
- Strong written and verbal communication skills, including fluency in oral and written English, with the ability to interpret data sufficiently to allow confirmation of associated text descriptions.
- High attention to detail and an ability to retain focus over an extended period.
- Flexible and adaptable, as oncology clinical research is a very dynamic field.
- Requires the ability to use a personal computer for extended periods of time.
Responsibilities
- Provide quality control (QC) review of clinical regulatory documents.
- Collaborate with other members of the Medical Writing team to ensure that all QC findings are addressed as appropriate.
- Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
- Assist in the development of templates and standard operating procedures (SOPs).
- Assist in the production of high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the Medical Writing function
Benefits
- merit-based salary increases
- short incentive plan participation
- eligibility for our 401(k) plan
- medical, dental, vision, life and disability insurances
- leaves provided in line with your work state
- flexible paid time off
- 11 paid holidays
- additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
