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Sanofi Group Professional, PMF Documentation - Vaccines in Swiftwater, Pennsylvania

Job Title : Professional, PMF Documentation

Job Profile : Lean and Performance Global / Platform Professional

Division/Business Unit : PMF (Project Management Function)

Location : MB18

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES:

  • This position is an exempt position.

  • The position oversees the revisions, updates, and creation of Quality eDoc documents; i.e., standalone forms, logbook forms, graphic work instructions, Batch Records, Master Specifications, Standard Operating Procedures, along with other critical documents to maintain project and commercial production schedules.

  • Maintains a strong working relationship with teams; PMF, FFFIP, RA, QC, PQMR, QA, and other departments requiring document support through a foundation of trust, accountability and teamwork.    

KEY ACCOUNTABILITIES:

  • Oversees the authoring of Batch Records, Master Specifications, Standard Operating Procedures, Standard Work Instructions, and other critical documents. 50% of time

  • Oversees and provides direction to find resolutions to problems impacting the document process. 10% of time

  • Coordinates/tracks all official documentation review and approval workflows within Quality eDoc ensuring deadlines are met. 10% of time

  • Tracks Change Controls and CAPA action items within the Trackwise system and is responsible for Action Item closures. 5% of time

  • Participates in scheduled training and stays abreast of Sanofi best practices. 5% of time

  • Regularly meets with SMEs to determine subject material to be written, regarding documentation and updates. 5% of time

  • Manages logbook process (creation, revision, and distribution). 5% of time

  • Provides status updates of documents and other quality systems. 5% of time

  • Participates as a project core team member that has document impact. 5% of time

CONTEXT OF THE JOB/MAJOR CHALLENGES:

  • Experience with normal Sanofi business processes, including but not limited to: Quality eDoc, SAP, Trackwise, Sharepoint, DISC, INIT, eBuy.

  • Demonstrates strong oral and written communication skills.

DIMENSIONS/SCOPE:

  • The Professional, PMF is responsible to contribute to the operating expense budget of approximately $3M.

  • This position has no direct reports.

  • Participates in Product Launch efforts and support PMF and FFIP teams responsible for Product Launch and Project Activities.

REQUIREMENTS:

Education/Experience:

  • Preferred Bachelor’s degree from an accredited college or university and a zero to three (0-3) years of experience working as a Technical Writer.

Preferred Qualifications:

  • Experience managing people.

  • A zero to three (0-3) years of experience as a Technical Writer within a Pharmaceutical/Biotech/Medical Device Company

  • Excellent interpersonal and communication skills

  • Attention to detail

  • Ability to manage conflict and develop customer solutions

Competencies:

  • Entrepreneurship - Level 1

  • Change and Innovation - Level 1

  • Team Performance - Level 1

  • Effective Communication - Level 1

  • Company Spirit - Level 1

  • Strategic Thinking - Level 1

Job Specific:

  • Project Delivery and Management. - Level 1

  • Formulation, Filling and Inspection Technical Knowledge. - Level 1

  • Building Utilities Knowledge. - Level 1

  • Customer Support. - Level 1

  • Operational Experience. - Level 1

  • Ability to prioritize amongst many good improvement opportunities. - Level 1

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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