At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
CVS Health Product and Regulatory Approvals Consultant in WORK FROM HOME, North Carolina
Responsible for supporting a wide variety of regulatory filing, project and support services to the Product and Regulatory Approvals Senior State Consultants, Advisors and Managers. Consultant will be responsible for the preparation, submission and approval of regulatory form filing submissions and DOI inquiries. Consultant must possess the ability to manage multiple priorities under tight deadlines to advance speed-to-market expectations and meet regulatory requirements. Consultant will perform a wide variety of tasks, including:• Preparing routine regulatory filings/follow-ups.• Drafting correspondence using existing procedures and precedence.• Filing standard forms and related materials that meet regulatory and legal requirements.• Identifying issues that need resolution using existing rules/regulations/guidelines.• Supporting State Consultants and Advisors with regulatory review activities including: objection response support, loading of forms in filing system, redlining, pdf, historical filing research/retrieval, etc.• Acts as a reference (resource) in specified areas of expertise.• Maintaining positive, productive relationships with customers and regulatory contacts.• Producing a variety of correspondence using the appropriate software.• Performing manipulation of text from various types of source information and processing documents of a varied nature to final form.• May participate in special projects/assignments.
- 2 years of experience in an office environment
COVID-19 Vaccination Requirement
CVS Health requires its Colleagues in certain positions to be fully vaccinated against COVID-19 (including any booster shots if required), where allowable under the law, unless they are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents them from being vaccinated.
If you are vaccinated, you are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status within the first 10 days of your employment. For the two COVID-19 shot regimen, you will be required to provide proof of your second COVID-19 shot within the first 45 days of your employment. Failure to provide timely proof of your COVID-19 vaccination status will result in the termination of your employment with CVS Health.
If you are unable to be fully vaccinated due to disability, medical condition, pregnancy, or religious belief, you will be required to apply for a reasonable accommodation within the first 10 days of your employment in order to remain employed with CVS Health. As a part of this process, you will be required to provide information or documentation about the reason you cannot be vaccinated. If your request for an accommodation is not approved, then your employment may be terminated.
SERFF filing experience is desired.• Ability to manage multiple priorities under tight deadlines to advance speed-to-market expectations and meet regulatory requirements.• Intermediate (or above) expertise in Microsoft Suite, including Word and Teams.• Excellent communication and organizational skills.
HSD or GED requiredBachelor’s degree preferred
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.