deputy Manager - ttWipro

General Overview
The primary function of this Subject Matter Expert (SME) position is to bring customer facing and inward facing thought leadership experience to Wipro's Offerings in any of the Life Science Domain as below * Risk Management
Health Hazard Assessment/Evaluation
Risk Mgmt. Plan & maintenance
Risk Evaluation and Mitigation Strategy
Regulatory services
e MDR reporting
EU 2017/745 compliance (MDR)
EU 2017/746 compliance (IVDR)
Publishing, Artwork and Labeling
Dossier Preparation & Submission
Standard and regulation - Implementation & Upgrades
Clinical Safety Management
Case Processing-Clinical Trials
Regulatory Submissions
Periodic & Aggregate Safety reports (DSUR, PSUR, PBRER)
SSCP as SSP, as per EU MDR & IVDR
Medical & Scientific Writing
Safety report writing-PSUR, DSUR, PBRER, PADER, ASR, addendum
Regulatory and Scientific writing for Medical Devices & IVD
Clinical Data Management
Class IIb and Class III devices
Study Setup, Conduct and Closeout
Expertise in Device Domain CDISC Data Standards
Post Market Surveillance
ICSR Management & Regulatory Submissions
Device Product Complaints Mgmt.
Legal complaints handling
Literature search and review
Signal Detection-Surveillance Mgmt.
PMS Report writing
Medical Affairs support
Medical Content & Scientific writing
FAQ management
Literature review and monitoring
CER, PER and Stability report writing as per MDR and IVDR
Medical Information Contact Center (AE/PQC/MI)
Responsible for providing in depth subject matter expert level knowledge through these crititcal areas:
Customer facing: During discussions with potential customers, bring to bear extensive knowledge of the field, and explain not only how our service ranges would suit them, but what they should be doing relating to the services mentioned above. Assist customers in overcoming the issues and assist them in navigating through their concerns is an essential component. Lead Business Development activities (e.g. Workshops) on our customer projects
Inward facing: Internally, this position will provide direction to help develop and design training structure, training modules, domain academies, SOPs, etc. Working with different individuals involved, assist in the ongoing projects as well as the development of skills for new offerings. The SME will be responsible for solidifying and extending these capabilities, including the definition of new capabilities to help support in decision making. The SME will be responsible for identifying and maintaining relationships with development partners and monitor the development process of these strategic extensions.
Should help to establish the best practice where it does not yet exist. Prepares and delivers subject matter presentations, white papers, training, etc
Closely work with customer & Delivery stakeholders for developing knowledge and skills of the resources
Provide strategic direction through insights.
Responsible for improving overall quality of training
Responsible for rigorous planning of New hire, Refreshers, Skill Improvement Training & implementation.
Manage & lead Client Visits, Business Reviews, Plan & facilitate Due-diligence.
Explore & incorporate capabilities and current engagements with client within Wipro for added differentiation and/or leverage.
Improve efficacy of training by exploring new training methodologies
Ensures adherence to quality standards and reviews project deliverables.
Provides business guidance to project team.
Under general direction, responsible for all aspects of the development and implementation of assigned Training projects and provides a single point of contact for those projects
Leads small to medium sized teams
Maintain Training records and database of all training materials
Minimum 7 years of experience in any of the domains mentioned above.
Training Experience preferred
Experience working with big and extended team
Graduate in Life Science Domain, additional education, specialization, certification preferred
Wipro

Cebu City, Cebu
Permanent
Full-time