Jobs
>
New York City

    Senior Associate, Regulatory Affairs Labeling Compliance - New Jersey, United States - Endo

    Endo
    Endo New Jersey, United States

    3 weeks ago

    Default job background
    Description

    Why Endo?

    We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

    At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

    The Regulatory Affairs Labeling Senior Associate is a key member of the Regulatory Affairs Labeling team and will report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the development/revision of labeling content along with the review and approval of all Regulatory Labeling text documentation for Labeling Updates (SLC, RLD, FDA Letters) for all Endo sites. The Regulatory Labeling Senior Associate will be expected to work in an environment that requires strict adherence to procedures necessary to ensure error-free labeling and FDA submissions.

    • Coordinate all labeling development, reviews, and approvals through the RA labeling group.
    • Review of regulatory documentation pertaining to NDA, ANDA and post approval submissions for labeling revision verification.
    • Proofread and review in-house and vendor proofs for labeling components for all Par sites, Third Party and special projects.
    • Review the Labeling section of NDA and ANDA Annual Reports.
    • Review all Brand and Generic Structured Product Labeling (SPL) documents for each Regulatory Labeling Submission.
    • Prioritize workflow to meet critical timelines which are consistent with departmental and company objectives.
    • Work closely with the Graphics Department regarding all in-house artwork.
    • Monitor graphic development of relative labeling components for all generic products.
    • Provide support to internal departments, customers and vendors pertaining to labeling requests, inquiries, issues, and responses.
    • Support implementation and use of documentation systems/tools, e.g. Docuproof.
    • Work with cross functional team members both within Endo and with Partner Companies.

    Commitment to Diversity, Equity, and Inclusion:

    At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

    EEO Statement:

    At Endo we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

  • Meet

    Associate Director, Global Regulatory Labeling

    4 days ago

    Meet New Jersey, United States

    Meet's partenered with a global pharmaceutical manufacturing company on an exciting new search for an Associate Director, Global Regulatory Labeling · You'll be serving as the GRA labeling experit for the Global Regulatory Team and independently provide strategic and operational ...

  • Partnership Employment

    Director of Quality Control

    1 week ago

    Partnership Employment New York, United States

    Our client, a well-known fast casual chain, is looking to hire a Director of Quality Control in their Bronx office. Opportunities to grow within the organization as they continue their rapid expansion by opening new restaurants and having their products in big name retailers. · ...

  • HirePower

    Clinical Laboratory Technologist

    3 weeks ago

    HirePower New York, United States

    Job Summary · We are looking for individuals to join our client's team as Clinical Laboratory Technologist – Histology. You will assist the Supervisor in the daily technical operations of the Pathology Laboratory. Additionally, work Independently under general direction to addres ...

  • IMCS Group

    Clinical Laboratory Technologist

    3 weeks ago

    IMCS Group New York, United States

    Job Title: Clinical Lab Technologist · Location: New York, NY 10002 · Payrate: $65/hr · Shift: 10a.m-6p.m. M-F · Contract Duration: 13 Weeks · Job Duties / Responsibilities: · • Collecting, labeling, and processing specimens with utmost attention to detail and adherence to strict ...

  • WorldWide Electric Corp

    District Sales Manager Position

    4 days ago

    WorldWide Electric Corp New York, United States

    WorldWide Electric is a national supplier of electric motors, motor controls, and gearing both in private labeled lines and manufacturer's brand labels, some of which are well known throughout the world. We are seeking highly motivated outside salesperson. All necessary product a ...

  • Beauty by Imagination (BBI)

    Graphic Designer

    16 hours ago

    Beauty by Imagination (BBI) New York, United States

    Beauty by Imagination · Graphic Designer · Hybrid · Position Overview: · A dynamic designer, who is initiative-taking, executes eye-catching visual creative at an elevated level, and can work on multiple assignments whilst always maintaining a high integrity of creative. The Des ...

  • Mazz NYC Inc.

    Logistics And Shipping

    1 week ago

    Mazz NYC Inc. New York, United States

    Company Overview: · Mazz NYC is a distinguished luxury business, dedicated to servicing major retailers and e-commerce platforms. We specialize in providing access to current season luxury fashion at discounted prices. Our core expertise lies in sourcing and supplying luxury prod ...

  • Sollis Health

    Radiology Technologist II

    1 day ago

    Sollis Health New York, United States Full time

    In the role of a Radiology Technologist II at Sollis Health, you will be responsible for the operation of our CT and X-ray equipment, performing diagnostics and ensuring that proper information has been obtained. You will also be trained and certified on how to run lab testing in ...

  • SpiriTrust Lutheran

    Med-Tech, The Village at Sprenkle Drive

    5 days ago

    SpiriTrust Lutheran York, United States

    SpiriTrust Lutheran is now hiring a Part Time Evening Shift or PRN Med-Tech. · *Must have experience as a PCA or RA in Long Term Care to be considered.* · Education/Training: High school diploma or equivalent. Must successfully complete the Department of Human Services direct car ...

  • Solomon Page

    Environmental, Health,

    2 weeks ago

    Solomon Page New Jersey, United States

    We are looking for Environmental, Health, & Safety Assistant Manager for a top beauty company in NJ Candidates must have managed a chemical waste program before. The US Research and Innovation (R&I) Environment, Health & Safety department provides direct support to and collaborat ...

  • Citarella

    Prep Cook

    1 week ago

    Citarella New York, United States Regular Full time

    Job Description · Citarella, The Ultimate Gourmet Market, is seeking two in-store Prep Cooks to join our Village store. This new role is responsible for the preparation and maintenance of various prepared foods such as rotisserie chicken, charcutier/deli meats and cheese, baked ...

  • Coltech Global

    Azure Active Discovery Engineer

    1 week ago

    Coltech Global New York, United States

    W2 - Hybrid in New York · My client is looking for a Senior Azure Active Directory Engineer to ensure the security, efficiency, and reliability of our Azure Active Directory infrastructure. The role involves designing, implementing, and maintaining Azure Active Directory solution ...

  • 20 Saia Motor Freight Line LLC

    Dockworker

    3 weeks ago

    20 Saia Motor Freight Line LLC Newark, United States Full time

    Full Time and Part Time opportunities available · Is your career taking you where you want to go? · When it began in 1924, Saia LTL Freight covered a two-state area: Louisiana and Texas. Today, Saia is one of the most successful carriers in the U.S., providing nationwide less-t ...

  • NYC Health + Hospitals

    Clinical Lab Technologist Level IV

    4 weeks ago

    NYC Health + Hospitals New York, United States

    About NYC Health + Hospitals: · Since 1875, South Brooklyn Health has established its reputation for clinical excellence and culturally competent care. It has designations as a Certified Percutaneous Coronary Intervention (PCI) Center, an Advanced Primary Stroke Center, an accred ...

  • WellSpan Health

    Pharmacist (Inpatient)- York Hospital Acute Care Pharmacy - Day/Eve

    2 weeks ago

    WellSpan Health York, United States Full time

    Schedule · Hours: Monday - Friday, Day/Evening · Rotation: Weekend · General Summary · Level III Pharmacists possess the expertise and advanced knowledge to be viewed as a department expert in either the operations or clinical domain. The primary responsibility of the Level I ...

  • AMS Staffing Inc.

    Legal Administrative Support

    5 days ago

    AMS Staffing Inc. New York, United States

    Please send resume in WORD format should you be interested in the following Legal Administrative Support (contract) position located in New York, NY. This is an open-ended contract position with a possibility of going full-time. The hourly pay range for this position is $40-45/hr ...

  • Vista Global

    Human Resources Coordinator

    1 week ago

    Vista Global New York, United States Permanent Full time

    Job Profile · Human Resources Coordinator is available onsite in Columbus, OH. The HR Coordinator will provide support to the Human Resources Department on a broad range of human resource activities and projects. · Jet Select is an affiliated operating partner of Vista in the ...

  • WellSpan Health

    Certified Pharmacy Technician

    3 weeks ago

    WellSpan Health York, United States Full time

    Schedule · Full Time · Hours: 2pm to 10:30pm Monday - Friday · Rotation: Every 4th Weekend and every 4th Holiday · General Summary · Certified Pharmacy Technician I assists with preparation and distribution of medications. The Certified Pharmacy Technician I position requires s ...

  • Crothall Healthcare

    Sterile Processing Assistant Director

    5 days ago

    Crothall Healthcare New York, United States Full time

    Crothall Healthcare Salary: · Other Forms of Compensation: · Pay Grade: 13 · Crothall Healthcare is a Compass One Company that provides specialized, high-quality, innovative, and responsive support services exclusively to the healthcare industry. Crothall serves many of th ...

  • Ironwood Pharmaceuticals

    Clinical Sales Specialist

    2 weeks ago

    Ironwood Pharmaceuticals New York, United States Full time

    This position will focus on parts of Queens, Brooklyn and the Upper East Side of Manhattan. · Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patien ...