Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job Title: Technical Writer

Location: Pearl River, NY

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

• The Technical Writer will be responsible for creating and finalizing comprehensive technical documentation related to the manufacturing process of Flublok Drug Substance. Working with a high degree of autonomy, the Technical Writer will draft and complete a wide range of documents essential to the manufacturing process. These documents include, but are not limited to, Change Controls, CAPAs, protocols, standard operating procedures, formal memos, and other technical materials.

• The Technical Writer will be responsible for inputs to completion and status data of work assignments in applicable software for reporting purposes which will require strong Project Management skills.

Key Accountability (% of time):

• Documentation (70%): Initiate, draft, and finalize documentation related to the manufacturing process. This includes, but is not limited to, change controls, CAPAs, protocols, standard operating procedures, and other technical documents.

• Collaborate (20%): Work cross functionally to ensure accurate descriptions of process, equipment, procedures, and all other technical aspects. Maintain high degree of awareness of Deviation Reports generated by Manufacturing Principal Investigators to assist, when required, in rework of verbiage as requested by Quality Assurance.

• Problem Solving (5%): The Technical Writer is expected to collaborate effectively across functions. When roadblocks arise, the Technical Writer is responsible for proactively addressing and resolving the issue. If the problem cannot be resolved independently, they are expected to escalate it appropriately to ensure timely resolution.

• Communication (5%): The technical writer provides status updates on all documents under their control. The technical writer attends check-ins as necessary and can provide accurate, concise, and complete updates on work status.

About You

Education/experience:

• Minimum bachelor’s degree (preferably in Science or Life Sciences) AND experience in a cGMP controlled/ pharmaceutical industry.

Certifications:

• None required, but certifications relevant to the position are preferred.

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All 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, gender identity or expression; 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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.