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Posted: Sunday, February 4, 2018 6:11 PM

Requisition ID 54175BR
Title Senior Attorney: Clinical, Medical and Regulatory
Job Category Legal and Compliance
Job Description Purpose
Provide legal counsel to global healthcare company on relevant issues involving application of U.S. law, regulations, and industry standards. The role will be within a legal team dedicated to providing legal guidance to a broad spectrum of internal stakeholders (Clinical, Medical and Regulatory, Commercial, and Compliance).
Reports to Senior Corporate Counsel.
Essential Functions
Provide legal support to Clinical Trial Management team, Clinical Medical Regulatory (CMR) Operations (including functions such as Product Safety, Medical Education, Med Info, and Quality), and Regulatory Affairs. Assist with the development or revision of policies and develop and facilitate legal training as needed. Draft, review and negotiate contracts, particularly clinical trial agreements and service agreements. Keep abreast of regulatory developments affecting Company and generate legal strategies to resolve issues. Anticipate potential obstacles in obtaining desired regulatory outcomes and work with key stakeholders to generate and implement response strategies. Assist Quality organization and Regulatory Affairs in handling for audits and inspections by regulatory authorities, responding to FDA Form 483s and warning letters, developing remediation work plans, and conducting market withdrawal/recall/field action analyses. Advise on compliance with post:market regulations, including adverse event reporting and pharmacovigilance, recalls, and good manufacturing practices. Monitor and remain current on regulatory and FDA policy issues. Work closely with Regulatory and Public Affairs on developing company policy positions. Draft comments on proposed laws and regulations, FDA guidance documents, and industry group policy positions.
Physical Requirements
Travel 0:20. Position located in Plainsboro, NJ.
* A Bachelors degree, JD degree and state bar admission required
* Minimum of 6 years legal experience
* Some government agency and in:house experience preferred
* Experience advising on laws, regulations, and industry standards impacting the life sciences industry required
* Demonstrates comprehensive knowledge and understanding of legal concepts, principles, and practices
* Displays expertise in FDA regulatory law including:
* Good Clinical Practices (GCP)
* Good Manufacturing Practices (GMP)
* Good Pharmacovigilance Practices (GVP)
* FDA regulations and guidance concerning advertising, promotion, and labeling
* Prescription Drug Marketing Act (PDMA)
* PhRMA/BIO codes
* FDAMA 114
* REMS requirements
* Has a deep understanding of the pharmaceutical and biotechnology industry and business model
* Possesses strong communication and time management skills, the ability to handle multiple projects simultaneously, and effective collaboration with other functional support groups and line of business
* Demonstrates strong ability to collaborate, work independently, and utilize problem:solving skills, creativity, and initiative. Strong commitment to ethical standards
Novo Nordisk is an Equal Opportunity Employer : M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation , please Apply at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Department LCA : LEGAL AFFAIRS (3)
Position Location US : Plainsboro, NJ
City Plainsboro
State/Provinces US : NJ
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. Thats why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, in


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