QC Medical Writer

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 womens 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. For more information on SMPA visit our website or follow us on LinkedIn.

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 Bachelors 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 peoplemanagement 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

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Drug Screening Requirements
Applicants for sales/field manufacturing or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital domestic partnership or civil union status; sex gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please contact SMPA at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.