Urgent need Operations/Project Management - Technical Project Manager III, 6+ months, REMOTE

View this email in your browser   We have an urgent requirements Can you please let me know do you have any interest/resumes for below positions Reply me with Updated Resume and Rate on C2C or W2 ? ASAP.   Job: Operations/Project Management - Technical Project Manager III Location: REMOTE Duration: 6+ months   You should have minimum 12+ years of labelling experience and have good knowledge of end to end labelling process and experience working with Health Authorities (HAs) Regulatory Framework.   Responsibilities ·         In this role, you will be responsible for all the activities related to. ·         Monitoring and developing continuous improvement proposals on the processes. ·         Maintain a staff of skilled resources to meet deliverables ·         Communicate issues and resolve in an appropriate time-frame. ·         Ensure adherence to agreed-to work practices. ·         Meet established submission timelines and quality standards. ·         Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labeling. ·         Ensure collection of metrics required ·         Maximize speed and minimize cost ·         Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions. ·         Guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. This may also include Regulatory Authority driven documents such as the Core Safety Profile. ·         Guide and advise the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label. ·         Ensure that client is up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles ·         Project management to the Labeling Team throughout the entire process, from the decision to update a CDS/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. ·         Advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text. Requirements ·         Masters in Lifesciences or equivalent with 12+ years of experience in regulatory Affairs/Labeling or equivalent ·         Demonstrated knowledge and understanding of CCDSs, US and EU labeling and the dynamics of Labeling Team purpose and objectives ·         Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts ·         Strong knowledge of key regulatory and Labeling principles and SOPs ·         Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in presenting to senior management when required ·         Must be able to construct a Company Response (MAH response) for health authority questions ·         Previous strong client management experience required   Qualifications: Minimum qualifications ·         Life Science Graduate/Post Graduate Preferred Qualifications / Skills ·         Pharmacy/Science/Regulatory Affairs/Labelling Thanks and Regards, Manosh   Saturn Infotech, Inc. P: 267.820.9343 gmbabu@saturninfotech.com gtalk: manoshj4@gmail.com​​   Click to edit Email Preferences or Unsubscribe from this list. Saturn Infotech, Inc. 1120 Welsh Road, Suite 110 North Wales, PA 19454 - USA