The Position
Responsibilities
Accountable for identifying, planning, and tracking documentation deliverables for the business function according to the Product Development Process (PDP) and Quality System processes (EOL, DC, DCO process).
Supports the business team with planning, scheduling, tracking and managing documentation deliverables.
Ensures project documents are complete, consistent, and conform to quality system standards.
Participates in initiative planning and advises business leadership on best practices, tailoring of deliverables, timelines, and risks.
Responsible for managing activities and resources associated with Documentation Management according to approved procedures such as document approval, distribution, location, availability, records retention and document formats and numbering schemes to be used in creating and changing items (documents and parts) that must be revision controlled under a formal change control process.
Responsible for developing a calendar of deliverables that spans all the relevant activities being driven by the Oncology Assay Business Team
Quality Management System (Agile) exposure; ability to manage Design Change control for processes including Post Launch Review, End of Life, Marketing Notifications, New part number creation, etc) with a focus on managing the review and approval workflows within the quality system to deliver solutions in a timely manner.
Participates in and contributes to the International Business Team meetings (IBT) and affiliate meetings
Identifies, generates and analyzes reports and process metrics for key business needs
Other duties as assigned by management.
Work closely across functional teams on developing and delivering communication to support business needs\
Reviews proposed changes to Quality System templates to ensure alignment. Updates and maintains document generation templates, specifically Marketing Notifications.
Subject matter expertise on Business Processes and Work Instructions.
***Please note this is a 1-year contract position, eligible for extension***
***This role is a remote opportunity***
Skills
Ability to create documentation that is complete, consistent, and accurate.
Ability to plan project components and effectively report status to stakeholders.
MS Excel, Word, and PowerPoint proficiency
Google Suite collaboration experience
Good project management skills
Excellent team skills, organizational skills, and problem solving skills.
Strong communication and analytical skills
Proficient at presenting and fielding questions in front of large or small audiences.
Information Security and Data Privacy fundamentals
Genentech
Boston Massachusetts
United States
None
(No Timezone Provided)
The Position
Responsibilities
Accountable for identifying, planning, and tracking documentation deliverables for the business function according to the Product Development Process (PDP) and Quality System processes (EOL, DC, DCO process).
Supports the business team with planning, scheduling, tracking and managing documentation deliverables.
Ensures project documents are complete, consistent, and conform to quality system standards.
Participates in initiative planning and advises business leadership on best practices, tailoring of deliverables, timelines, and risks.
Responsible for managing activities and resources associated with Documentation Management according to approved procedures such as document approval, distribution, location, availability, records retention and document formats and numbering schemes to be used in creating and changing items (documents and parts) that must be revision controlled under a formal change control process.
Responsible for developing a calendar of deliverables that spans all the relevant activities being driven by the Oncology Assay Business Team
Quality Management System (Agile) exposure; ability to manage Design Change control for processes including Post Launch Review, End of Life, Marketing Notifications, New part number creation, etc) with a focus on managing the review and approval workflows within the quality system to deliver solutions in a timely manner.
Participates in and contributes to the International Business Team meetings (IBT) and affiliate meetings
Identifies, generates and analyzes reports and process metrics for key business needs
Other duties as assigned by management.
Work closely across functional teams on developing and delivering communication to support business needs\
Reviews proposed changes to Quality System templates to ensure alignment. Updates and maintains document generation templates, specifically Marketing Notifications.
Subject matter expertise on Business Processes and Work Instructions.
***Please note this is a 1-year contract position, eligible for extension***
***This role is a remote opportunity***
Skills
Ability to create documentation that is complete, consistent, and accurate.
Ability to plan project components and effectively report status to stakeholders.
MS Excel, Word, and PowerPoint proficiency
Google Suite collaboration experience
Good project management skills
Excellent team skills, organizational skills, and problem solving skills.
Strong communication and analytical skills
Proficient at presenting and fielding questions in front of large or small audiences.
Information Security and Data Privacy fundamentals