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.
Senior Analyst, Regulatory Affairs – ZyVet Animal Health Inc
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.
- 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.
- 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.
- 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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Analyst, Channel Operations
Reporting to the Associate Director, Customer + Channel Operations, The Analyst will be the day-to-day operations support to a multi-channel account management team in the generic pharmaceuticals commercial and injectables market. The position not only manages channel customer data and vendor partners, but also performs critical analysis and reporting that is viewed consistently by senior management. This is a new position that requires a unique blend of skills and spans across multiple disciplines: supply chain, distribution, customer service, account management, analytics, and finance.
- Support Channel Operations in day to day activities related to master data management, IDN/Roster membership analysis and management, contract management and customer sales reporting
- Understand contracting strategies and maintain current knowledge supporting data structures, business processes, and documentation for contracted accounts; assist with any decisions and changes required to adapt to business needs.
- Liaise with the Membership Management and Chargeback operations team to ensure timely and complete and accurate processing of indirect channel data.
- Execute contract strategies. This includes contract set-up, membership management, and communications. Execute wholesaler notification regarding contract terms including sending non electronic Bid Awards daily to wholesalers to support accurate billing.
- Using data from the Office of Pharmacy Affairs, perform monthly a 340B membership verification and maintain eligibility in the transaction system as needed. Resubmit any claim lines that are found to be ineligible.
- Provide support to sales team through ad-hoc analyses that may be needed to help facilitate execution of sales strategy.
- Build strong relationships with key stakeholders built on trust, transparency and communication across Sales, Marketing, Supply Chain, Finance and Operations.
- Participate in special projects as assigned.
Competencies and Skills
- Bachelor’s degree or High School Diploma
- Ability to think through how decisions will impact Zydus, partners and customers prior to execution.
- Strong critical thinking and problem-solving skills.
- Strong verbal and written communication skills.
- Must demonstrate excellent organization and time-management skills.
- Ability to handle multiple projects and tasks in a matrix environment
- Model N or Revenue Management software experience a plus.
- Business Intelligence (BI) tools software experience a plus.
Salary commensurate with experience
401K and healthcare coverage