Junior Medical Writer Sciformix Corporation
THIS JOB HAS EXPIRED Responsibilities
Responsible and accountable for the general coordination and project management, communication and appropriate escalation.
Manage all timelines for assigned deliverables, ensuring all labeling projects meet expected and SOP milestones
Perform tracking and monitoring of various milestones
Manage key interactions with internal Sponsor contributing groups, reviewers, approvers and other stakeholders
To complete document compilation and publishing, including but not limited to, the collation of all necessary components, word processing, formatting and publishing
Manage and facilitate approval workflow, adhering to specified timelines and ensure deliverables meet highest level of quality via consistency of information, completeness, proper use of language and grammar, etc.
Is responsible and accountable for managing and facilitating the document review, including consolidating and resolving review comments and incorporating agreed upon reviewer comments into the document prior to final document approval.
Is responsible and accountable for managing and facilitating the approval workflow, adhering to specified timelines.
Is responsible and accountable for providing quality assurance, compliance with all applicable Sponsor SOPs, ensuring deliverables meet highest level of quality via consistency of information, completeness, proper use of language and grammar, etc.
Perform QC as defined in working guides throughout the workflow of the document by applying knowledge of labeling regulatory formatting requirement and guidance
Attend labeling team meetings and other necessary meetings held between Sponsor personnel and the Sciformix assigned LOS.
Bachelor?s degree in Medical Science/Pharmacy/ Masters in related science area
At least 1 year experience in the pharmaceutical/biotechnology industry
Good understanding of regulatory requirements and ICH-GCP guidelines
Technical proficiency with Microsoft Office suite of applications
Excellent verbal and written communication skills
Attention to detail & concern for quality
Ability to analyze & synthesize medical information
Planning & prioritizing
||New Jersey |
THIS JOB HAS EXPIRED