Eric Lemon Email & Phone Number

New York, Ny, Us

New York, Ny, Us

Bagsværd, Dk

Bagsværd, Dk

Montgomery Township Fire District #1 is an autonomous entity funded through a municipal fire tax and governed by a five member Board of Fire Commissioners whose mission is to protect life, property, and the environment from damage due to fire, automobile, and environmental emergencies within our district and to assist neighboring communities in their mission to do the same.

Basel, Basel-Stadt, Ch

• Responsible for creation, updates and maintenance of NDA, BLA and ANDA labeling components for Sandoz products; approval authority for third party application holder’s AGx and ANDA products distributed in Sandoz branded labeling• Develops and coordinates labeling content with CMC for the approval of submissions to FDA; processes and confirms electronic submission files (SPL) in ALiCE (A4L) for eCTD initial filings, post approvals, listings and delistings• Ensures labeling artwork components and print production proofs are proofread and compared to accurately reflect the content creation or change while following the proper format based on FDA, US Customs and Sandoz requirements• Constant involvement with cross-functional teams internally and externally for new launch activities and product lifecycle maintenance; contributes key language to Pharmacovigilance, Quality, Legal, Supply Chain and Marketing for agreements• Applies and leverages labeling and general business knowledge in all phases of work; assesses gaps and aligns procedures and work instructions for lean processes while complying with FDA guidance and regulations• Functional Lead/Key User for Sandoz US Sites on assessing and aligning with the Artwork Harmonization Program to implement a lifecycle program for labeling creation, approval and site implementation for artworks• Mentors Level I - III Labeling Associates; willingly shares SME knowledge and guidance for growth of the department• Led the implementation of the Text Verification Tool (TVT) software to replace current system; created internal policies, procedures and work instruction; performed training and provided support as a Key User for Sandoz Associates• In-depth knowledge of TrackWise and AGILE change control systems as it applies to Sandoz process; “Go-To” Person

Bridgewater, Nj, Us

• Provided regulatory labeling support in the development, revision, review and approval of labeling content for submissions to FDA, as well as any postmarketing labeling changes and responses from the health authorities• Lead labeling artwork development and revisions through lifecycle coordination using the eDMS ELM• Proofread and compared new/updated artwork for accuracy while adhering to Valeant guidelines and regulatory requirements• Responsible for drug listing and providing labeling for periodic reports as per FDA requirements; monitor changes to Referenced Listed Drug (RLD) products; complete electronic drug listing for applicable updates per federal requirements• Liaise with internal cross-functional teams to ensure the accuracy of all information; coordinated approvals and cross-functional notifications of new/revised labeling content• Contributed to the development of labeling processes and procedures to enhance existing practices

Summit, New Jersey, Us

• Designed, proofread, circulated and released clinical pharmaceutical labeling and packaging components for delivery to packaging and manufacturing vendors for global clinical supply manufacturing• Accurately reviewed vendor proof artwork graphics and texts to confirm accuracy to the source documents manually; ensured strict adherence to FDA Clinical Labeling and EU Annex 13/Annex 6 guidelines• Proficient in proofreading multilingual global booklets that contain medical and scientific terminology, non-English text, non-Roman characters and right-to-left languages; coordinated with international regulatory reviewers for language accuracy• Designed and administered Microsoft SharePoint main and departmental sites for cross-functional visibility• Trained new group members on regulatory labeling guidelines, design and proofreading techniques during reorganization• Coordinated with packaging vendors for supply requests to schedule primary, secondary and labeled finished goods to meet study demand; coordinated finished goods for transfer to depots and sites

Deerfield, Illinois, Us

• Designed, proofread, circulated and released commercial pharmaceutical labeling components for regulatory submissions, packaging and manufacturing functions for global commercial supplies• Accurately reviewed internal artwork graphics and texts to confirm accuracy to the source documents manually and utilizing TVS system; ensured strict adherence to CFR 201, 210, 211 and corporate identity guidelines• Created Microsoft SharePoint Teamsite for tracking and metric gathering of multiple artwork projects within the group and shared across multiple functions for project visibility; improved approval and response times• Highly proficient in change control and Correct Action/Preventive Action (CAPA) processes utilizing TrackWise• Coordinated with cross-functional groups to include Regulatory Affairs, Marketing, Clinical Affairs, Trademarks, Engineering, Manufacturing to gather all pertinent change information and approvals • Member of Global Labeling Project Initiative for process improvement and global harmonization

Deerfield, Illinois, Us

• Performed annual record review to ensure proper disposition of records and documents• Effectively communicated with all department levels on record retention procedures• Conducted gap analyses; improved workflow processes in department; trained personnel on new processes• Archived electronic and physical documents; distributed documents upon request from all department levels• Verified and edited documents according to local and corporate requirements using a document change control system• Key role in improving facility Corrective Action/Preventive Action process; created reports for monthly review

Bachelor'S Degree, Recreation

Associate'S Degree