Who is Zydus

CAREER OPPORTUNITIES AT ZYDUS USA

Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality and affordable products. Our US leadership, which has over 60 years of US generic market experience, understands the customer’s business which allows Zydus the ability to provide unique models to help drive their customer’s success. Our parent company, Zydus Cadila, has a large presence in the global markets, including relationships with many top tier international pharmaceutical companies. Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India.

WARNING REGARDING FRAUDULENT JOB POSTINGS

Recently Zydus has learned of certain fraudulent job postings on sites such as Craigslist by persons claiming to be recruiters or agents for Zydus Cadila, but who are in no way affiliated with the company or any of its affiliates.  These positions do not exist and the advertisements are not authorized by Zydus or Zydus Cadila.

The fraudulent job postings are typically advertised without disclosure of the company’s identity and the applicant is directed to reply to the job posting only by email to a non-company email address.  Please do not provide your driver’s license, social security number, financial information or any other personal information to anyone claiming to be a recruiter for Zydus or Zydus Cadila through an online job posting.

If you have received any of these fraudulent offers of employment or if you are unsure about a job posting or offer of employment purportedly on behalf of Zydus or Zydus Cadila, please forward the offer or job posting to Zydus through this website.  If you are in the United States and have been a victim of this fraudulent job posting, you can file a report of the incident on the FBI’s Internet Crime Complaint Center website at www.ic3.gov.

Current Opportunities

Senior Analyst, Regulatory Affairs – ZyVet Animal Health Inc

Summary

The ideal candidate should possess an updated knowledge of the current FDA, COFEPRIS, USP and ICH guidelines, Hatch- Waxman Act, Drug User-Fee Act(s), Drug Supply Chain Security Act (DSCSA) and other relevant laws governing pharmaceutical industry. An ideal candidate should have sound understanding of various pharmaceutical dosage forms and pharmaceutical science along with pharmaceutical manufacturing process.

Responsibilities

  • Under the direction of management, to represent the US Animal Health Regulatory Affairs Pharmaceutical group on cross-functional pharmaceutical and/or biopharmaceutical project team(s), primarily companion animal species, providing strategic, proactive and timely regulatory expertise throughout the planning and execution of the project(s) or other related tasks.
  • Be primary point of contact for interactions with the Food and Drug Administration (FDA)/Center for Veterinary Medicine (CVM) in relation to the assigned products/projects. Will ensure that questions or requests are addressed in a timely manner.
  • To work with project team members, to develop content and structure of high quality regulatory submissions that fulfill regulatory requirements and the expectations of regulatory agency personnel.
  • To author or co-author high quality regulatory component documents used in the production of submissions that comply with regulatory requirements and expectations of regulatory agencies (primarily FDA/CVM) .
  • Responsible for providing strategic and tactical guidance throughout the planning/execution of projects.
  • Facilitate establishment inspections of API & Finished Dosage Form manufacturing sites.
  • Provide QA oversight to with respect to agreement and audit of all 3PL service providers, re-packagers, contract manufacturing organizations and contract research organizations.
  • Manages compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
  • Develops, translates, reviews (if relevant) and approves artwork and promotional copy to ensure regulatory compliance for submissions.
  • Uses available electronic publishing tools to compile, electronic or paper-based submissions necessary to meet regulatory requirements.
  • Provides executive summaries and status updates on product/project activities to key internal/external stakeholder.

Skills Required

  • Excellent oral and written communication and negotiation skills.
  • Very organized with strong attention to detail.
  • Functional knowledge of Microsoft platforms and associated Office suite programs that may include but are not limited to Outlook, Word, Excel and PowerPoint.
  • Experience with electronic submissions to regulatory authorities and/or project management experience would be a bonus.

Education/Experience

  • Bachelor’s or Master’s degree, in a relevant scientific discipline (animal science, veterinary medicine, immunology, toxicology/pharmacology or similar). DVM and/or PhD is highly desirable.
  • Minimum of three years’ experience in the animal health pharmaceutical or biopharmaceutical product development industry.
  • Regulatory affairs knowledge (especially regarding registration of animal health products with FDA-CVM), experience in developing regulatory submissions, and interacting with regulatory agency personnel are highly desirable. Experience in dealing with development and/or registration of biopharmaceutical products with FDA-CVM.

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    Licensed Medical Communicator

    Summary

    Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality and affordable products.  Our US leadership, which has over 60 years of US generic market experience, understands the customer’s business which allows Zydus the ability to provide unique models to help drive their customer’s success.  Our parent company, Zydus Cadila, has a large presence in the global markets, including relationships with many top tier international pharmaceutical companies.  Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India.

    The Licensed Medical Communicator (LMC) is responsible for assessing Adverse Events as well defining communication strategy to prepare the team for handling product complaints, Adverse Events and medical information requests. The LMC will be ensuring compliance to various guidelines around HIPAA, FDA and local regulations. The LMC will also be responsible for various business aspects concerning Safety Data Exchange with various business partners.

    Responsibilities

    • Create/revise Customer Care Center scripts, internal product training and global alignment of medical information standards and best practices.
    • Assess published literature and assist customer/HCP with respect to various technical aspect of the product from the approved literature
    • Liaise with formulation, quality, and regulatory team to gather critical technical aspect of the product and provide with technical guidance to MIS, DSA and MIC
    • Safeguard patient privacy and confidentiality by following the guidelines set forth in the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA)
    • Prepare, update and review Safety Data Exchange Agreements with various business partners and maintain its compliance
    • Ensure the cases are shared with relevant stakeholders as per the timelines defined in various SDEAs.
    • Follow up for HCP/ Pharmacist for critical adverse event as per the company SOP
    • Review, assess and analyze appropriateness of spontaneous adverse event categorization.
    • Responding and documenting calls in compliance with Regulatory and Legal demands.
    • Serve as a link between company and the patients or healthcare experts to provide valid information on product safety and manage adverse event and product complaint inquiries according to standard operating procedures.
    • Evaluate each case for its completeness and determine if the case can be closed by proper documentation.
    • Review the standard response database and/or the published literature to determine the best response. 
    • Evaluate each medical inquiry to determine its legitimacy and its relationship to an adverse reaction and/or product complaint
    • Tactfully handle adverse events associated with the off label, unapproved indication of approved products
    • Prepare and perform Health Hazard Evaluation with critical product complaints and adverse event
    • Draft new medical letters in response to inquiries and for inclusion into the medical information database.
    • Attend and participate in periodic department meetings
    • Responsible for evaluating and interpreting medical literature, abstract and writing medical information in various formats.
    • Present medical information/adverse event/product complaint trends to management.
    • Contribute to the training of new Medical Communications associates.
    • Present clinical data/information in managed care settings or professional meeting for specialty products as and when needed.
    • Participate in advisory board meeting with respect to various pregnancy registries
    • Assist management with respect to analyzing trend data and early signal detection
    • Prepare technical sales training materials and present to customer sales representatives for specialty product
    • Work with the management to ensure efficient and accurate performance of Medical Communications department.
    • Ensure Department training and SOPs are current and compliant.

    Skills Required

    • Detail-oriented with demonstrated editorial skills.
    • Familiarity with Drug Safety and Drug Information policies and procedures
    • Prior experience in endocrinology or hemostasis therapy areas preferred.
    • Strong presentation skills (knowledge of PowerPoint required).
    • Strong verbal and written communication skills.

    Education/Experience

    • Registered PharmD, BSN, MSN, MD or PhD in life sciences with relevant 4 years’ experience
    • Knowledgeable of HIPAA, FDA, MedDRA and Eudra Vigilance guidance
    • Hands on experience with safety database, i.e. ARGUS, ARIS-G, PVNet or others

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      Drug Safety Associate

      Summary

      Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality and affordable products.  Our US leadership, which has over 60 years of US generic market experience, understands the customer’s business which allows Zydus the ability to provide unique models to help drive their customer’s success.  Our parent company, Zydus Cadila, has a large presence in the global markets, including relationships with many top tier international pharmaceutical companies.  Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India.

      The Drug Safety Associate is responsible for executing US Adverse Event and Pharmacovigilance activities as required by FDA Regulations. The associate will provide support and oversight in drug safety related activities including Product Quality Complaints and Medical Information activities.

      Responsibilities

      • Serve as second line of contact for the incoming calls to medical affairs department
      • Intake new and follow up spontaneous Adverse Events and record the discussion in relevant AE worksheet
      • Writing case narratives for serious/non-serious, study reports and quality/product complaint reports prior to sign off by medical information specialist
      • Evaluate cases for seriousness and expectedness criteria
      • Enter in AE cases in safety database in timely manner for further processing by MIS and Pharmacovigilance Group.
      • Maintain Adverse Event and Safety database log and coordinate distribution of safety data as needed.
      • Maintain verification of reconciliation and email correspondence in Drug Safety shared drive
      • Distribute adverse event reports to plant QA/GPV/Partner companies in accordance with Safety Data Exchange Agreements (SDEAs)
      • Obtain follow-up information via mail or telephone from healthcare professionals and consumers as per the relevant SOP or as per the ongoing medical conditions.
      • Monitor status of follow-up letters to ensure follow-up information is requested in the required timeframes
      • Follow up with reporter/patient/HCP at defined interval either
      • Maintain US Adverse Event and safety database and coordinate distribution of safety data.
      • Interact with data intake and entry group to ensure complete quality and output and provide guidance on follow up as needed.
      • Handling Product Complaints related to Adverse Events.
      • Performing reconciliation with business partners and vendors for AE reports exchanges
      • Responsible for taking appropriate decisions by applying knowledge of FDA and ICH GCP and GVP standard regulations to write overall case summary.
      • Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required.
      • Assist with additional drug safety activities as required.
      • Perform retrospective equality review and document findings, and contribute to metric compilation
      • Support the identification of corrections and creation of updates in safety database following medical review.
      • Implement and execute QC on key fields for serious cases.
      • Offer during reviews and audits of safety data and database.
      • Perform Individual Case Safety Report (ICSR) processing activities within the safety database and do quality checks on the assigned ICSR.
      • Support Regulatory Inspections.
      • Accurately distinguish and analyze the ratio of risk and benefits of the drug that is marketed.
      • Conduct database searches, as necessary.

      Skills Required

      • Extensive working knowledge of FDA regulations, FDA guidance and ICH guidance; some familiarity exposure to EMEA regulations
      • In-depth understanding of the ICSR assessment and reporting process
      • Proficient in outlook, MS Word, PowerPoint and Excel.

      Education/Experience

      • Bachelor’s Degree in life sciences, pharmacy, nursing (RN, RPh) or combination of Health-Related Degree and clinical experience in a medical setting
      • Two years of experience in pharmaceutical drug safety/pharmacovigilance including experience in triaging of cases, coding of terms using MedDRA, data entry and narrative writing.
      • Hands on experience with safety database, i.e. ARGUS, ARIS-G, PVNet or other

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        Medical Information Specialist

        Summary

        Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality and affordable products.  Our US leadership, which has over 60 years of US generic market experience, understands the customer’s business which allows Zydus the ability to provide unique models to help drive their customer’s success.  Our parent company, Zydus Cadila, has a large presence in the global markets, including relationships with many top tier international pharmaceutical companies.  Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India.

        The Medical Information Specialist (MIS) is responsible for handling medical information, adverse events and/ or product complaints on behalf of Zydus Pharmaceuticals.  The MIS will be trained on policies and procedures in accordance with FDA regulations, MedDRA and internal PV SOPs as it relates to medical information, drug safety/surveillance, drug safety, and product quality. The MIS is expected to develop a high level of expertise in these areas and is continuously aware of changes in these regulations.

        The MIS will be trained on various disease states and products and be expected to maintain a high level of expertise in these areas.  In addition, the MIS will establish a high level of working knowledge about Company’s medical information databases.  As requested, the MIS will support the team to handle and complete various projects outside the scope of the Medical Information Specialist (MIS) role.

        Responsibilities

        • Review, assess and analyze appropriateness of spontaneous adverse event categorization.
        • Responding and documenting calls in compliance with Regulatory and Legal demands.
        • Serve as a link between company and the patients or healthcare experts to provide valid information on product safety and manage adverse event and product complaint inquiries according to standard operating procedures.
        • Handle phone and written disease state and product inquiries from physicians, other health care professionals, consumers and customer sales representatives and customer medical personnel according to protocol.
        • Review the standard response database and/or the published literature to determine the best response. 
        • Evaluate each medical inquiry to determine its legitimacy and its relationship to an adverse reaction and/or product complaint
        • Evaluate each adverse event and its possible association with an ongoing product recall
        • Prepare and perform Health Hazard Evaluation with critical product complaints and adverse events
        • Draft new medical letters in response to inquiries and for inclusion into the medical information database.
        • Attend and participate in periodic department meetings
        • Responsible for evaluating and interpreting medical literature, abstract and writing medical information in various formats.
        • Create/revise Customer Care Center scripts, internal product training and global alignment of medical information standards and best practices.
        • Present medical information/adverse event/product complaint trends to management.
        • Contribute to the training of new Medical Communications associates.
        • Present clinical data/information in managed care settings or professional meeting for specialty products as and when needed.
        • Participate in advisory board meeting with respect to various pregnancy registries
        • Assist management with respect to analyzing trend data and early signal detection
        • Prepare technical sales training materials and present to customer sales representatives for specialty product
        • Work with the management to ensure efficient and accurate performance of Medical Communications department.
        • Ensure Department training and SOPs are current and compliant.

        Skills Required

        • Detail-oriented with demonstrated editorial skills.
        • Familiarity with Drug Safety and Drug Information policies and procedures
        • Prior experience in endocrinology or hemostasis therapy areas preferred.
        • Strong presentation skills (knowledge of PowerPoint required).
        • Strong verbal and written communication skills.

        Education/Experience

        • BS Pharmacy, PharmD, BSN, MSN, MD or PhD in life sciences with relevant 2 years’ experience
        • Hands on experience with safety database, i.e. ARGUS, ARIS-G, PVNet or other

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          Medical Information Coordinator

          Summary

          Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality and affordable products.  Our US leadership, which has over 60 years of US generic market experience, understands the customer’s business which allows Zydus the ability to provide unique models to help drive their customer’s success.  Our parent company, Zydus Cadila, has a large presence in the global markets, including relationships with many top tier international pharmaceutical companies.  Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India.

          Medical Information Coordinator will perform activities to support processes and services for Medical Information. Product Complaints and Adverse Event (AE) Reports Correspondence, load documents into the system and generate reports. The coordinator will assist the team as needed, including general administrative functions. Continually seek out ways to enhance customer service experience both internally and externally.

          Responsibilities

          • Serve as first line of contact for incoming calls to Medical Affairs department and triage them accordingly.
          • Intake product complaint and record them as per the relevant SOP. 
          • Prepare and send prepaid envelope to obtain complaint samples for AEs and PCs
          • Follow up for the complaint samples as per company SOP and plant QA requirements
          • Receive and prepare CS log for incoming complaint samples and share with respective manufacturing locations.
          • Maintain monthly log of all adverse experience/product complaint reports. 
          • Prepare monthly reports of tabulations of product complaints/AE’s per the department request
          • Answer inbound lines and triage adverse events by referring to the appropriate Drug Safety Associate/Medical Information Specialist. 
          • Maintain log of frequently asked questions and communicate with various manufacturing locations to prepare for future product launches
          • Respond to all faxes, voicemails, emails, and Medical Information Requests that come from various sources
          • Check email and voicemail boxes daily and input information into appropriate database and either handle the call or triage the call to the appropriate Drug Safety Associate/Medical Information Specialist
          • Handle miscellaneous projects within the Medical Affairs Department
          • Assist in assessing various cases and prepare case closure documentation and share with respective manufacturing location.

          Skills Required

          • Possess basic writing skills
          • Communicates well via phone and writing
          • Proficient in outlook, MS Word, PowerPoint and Excel.

          Education/Experience

          • Bachelor’s degree in science field or relevant work experience
          • Basic understanding of pharmaceutical industry
          • Pharmacy Technician background preferred

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