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.

Essential Functions Required for Job

• 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

Knowledge, Skills and Abilities (general & technical):

• 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.

Education & Experience 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.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

This is an individual contributor role and does not have direct reports or formal people-management responsibilities.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

$100,900.00 - $126,100.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.