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.
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.
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.
- 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.
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
Entrepreneurship - Level 1
Change and Innovation - Level 1
Team Performance - Level 1
Effective Communication - Level 1
Company Spirit - Level 1
Strategic Thinking - Level 1
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.
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.