Summary of the Position:
Alcon is looking to hire MAP Operations Specialist. Product Regulatory Affairs Documentation work includes some or all of the following: Ensuring a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements •Complying with regulatory agency requirements •Maintaining the technical and non-technical documentation change system •Developing and implementing procedures to classify and maintain records •Interpreting and enforcing all documentation formatting, standards, policies, and operating procedure requirements In some organizations, may identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
Major Accountabilities
Major accountabilities for the position include:
Supports/assists in acting as a centralized knowledge hub of MAP and provides guidance to project owners/agencies/reviewer on the process to streamline material review Collaborates with Brand to set prioritization of review to manage review priorities against business needs, assist in triage of materials for appropriate review and provides guidance on submission readiness. Supports MAP review meetings to ensure all review requirements and processes are followed, effective time management, and assists in promoting collaborative problem-solving and teamwork. Prepares pertinent approval documentation and ensures distribution of the materials submitted to reviewers for compliance review. Reviews materials submitted for review to ensure readiness according to established criteria and templates as applicable (e.g. proper referencing and annotations) Tracks all submissions to ensure task completion and for monthly reporting purposes (metrics) to senior management Ensures effective implementation and use of any electronic review tools Assists in identifying team/process/system issues and assists team to address collaboratively, recommending systemic process improvements. Reviews, edits and approves all assigned project deliverables against project documentation and specifications prior to client delivery within established timelines Supports work of, or acts as proof copy editor as needed to ensure that all required changes are addressed, and the material is complete and accurate. Prepares pertinent report documentation (e.g., metrics and monitoring reports) and ensures distribution of reports. Assists with special projects as needed (e.g. development of new SOPs) Remain current on all compliance requirements and processes as they pertain to promotional practices and guidelines established by the corporation.
Key Performance Indicators
Education:
Bachelor's degree (Science background will be a plus
Languages:
Excellent command of written and spoken English, other major languages are a plus.
Experience:
2 - 3 years of experience.
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