New Jersey Other Job Listings

Workable

Regulatory Support

Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: • experience in pharmaceutical environment. • Experience in regulatory environment is required. • High level exposure or knowledge about FDA inspection and internal audit process. • Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : • Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. • Represents Regulatory Affairs on cross-functional project teams. • Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. • Work with subject matter experts, and cross functional departments to support business needs. • Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. • Gather and assemble information necessary for submissions in accordance with regulations/guidance. • Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. • Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. • Maintain knowledge of local and global regulatory submission requirements. • Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. • Provide Regulatory Affairs support during internal and external audits and inspections. • Exposure in Change management process, requirement gathering, qualifying the changes etc., • Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. • Consistently support for regulatory systems access and change management. • Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: • Bachelors’ degree, preferably in a life science or a related field • 5 to 10 years of experience in pharmaceutical environment. • Experience in regulatory environment is required. • Excellent written, verbal communication and presentation skills. • High level exposure or knowledge about FDA inspection and internal audit process.

Jersey City, NJ, USA

Negotiable Salary

Senior Manager, Market Access Contracting Operations - Temporary Contract63392055111811121

Workable

Senior Manager, Market Access Contracting Operations - Temporary Contract

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. Position Summary: We are seeking a highly motivated Senior Manager (Contractor) to support our Contracting Operations function within the Market Access organization. This individual will be responsible for the day-to-day management of contract operations activities across pharmaceutical pricing, contracting, and rebate agreements with payers, PBMs, GPOs, and other stakeholders. The role will focus on contract lifecycle management, operations execution, and process improvement to ensure compliant and efficient contract implementation. Key Responsibilities: Contract Lifecycle Management: Support drafting, execution, and administration of payer, specialty pharmacy, and/or GPO agreements (e.g., rebate, discount, and data sharing contracts). Operational Execution: Oversee contract set-up, terms validation, implementation in applicable systems, and monitor performance against terms. Rebate Processing & Validation: Collaborate with Rebate Operations and Finance teams to validate rebate calculations and ensure accurate and timely payments. Cross-Functional Collaboration: Partner closely with Legal, Finance, Pricing, Market Access, Trade, and Compliance teams to support contract alignment and implementation. System Management: Experience with contract management and rebate systems (e.g., Model N, Revitas, Vistex, iContracts) for contract intake, validation, and performance tracking. Audits and Compliance: Maintain documentation and audit trail in support of internal controls, SOX compliance, and government pricing implications. Process Optimization: Contribute to identifying and implementing improvements to contract processes, templates, and governance. Salary Range: $75-$85hr/DOE Requirements Qualifications: Bachelor's degree required; advanced degree or MBA preferred. 7 years of experience in contract operations or market access within the pharmaceutical, biotech, or life sciences industry. Strong understanding of payer contracting, rebates, and pricing strategies. Experience working with and managing BPO service providers. Familiarity with government pricing implications (Medicaid, 340B, Medicare Part D) is a plus. Excellent project management, analytical, and organizational skills. Ability to thrive in a fast-paced, matrixed environment with shifting priorities. Strong attention to detail and ability to manage multiple contracts and deadlines. Preferred Experience: Experience supporting product launches or market access readiness. Working knowledge of commercial agreements with PBMs, IDNs, or Specialty Pharmacies. Experience with audit preparation and documentation in highly regulated environments. Hands-on experience with contract and rebate management systems (e.g., Model N, iContracts, Vistex, etc.). A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Princeton, NJ, USA

$75-85/hour

Hybrid Partner-Level Privacy Law63391998267009122

Workable

Hybrid Partner-Level Privacy Law

Hybrid Law Firm Partner Privacy Salary Range of 225K-250K Plus Yearly Bonus Offered, Equating To 1M-2M Excellent compensation package plus benefits Bergen County, NJ A nationally recognized law firm is seeking a seasoned Privacy and Data Protection Partner to help expand a rapidly growing Privacy and Data Protection Practice. This strategic hire will support increasing client demand and strengthen the team’s ability to counsel sophisticated clients on complex and evolving data privacy issues. About the Role: The ideal candidate will bring extensive experience advising clients on U.S. and international privacy laws and frameworks, providing practical and forward-thinking legal guidance on compliance, risk management, incident response, and strategic data use. You’ll serve clients across industries such as technology, healthcare, education, media, retail, and financial services. In this role, you’ll collaborate closely with other senior attorneys and practice leaders, mentor junior lawyers, contribute to thought leadership, and play a key role in expanding one of the firm’s fastest-growing practices. Why Join: This opportunity offers a national platform and entrepreneurial environment where experienced attorneys can lead and grow. The Privacy and Data Protection team is collaborative and interdisciplinary, working closely with practices across corporate, employment, healthcare, and IP law. Attorneys are supported by strong administrative resources, a national footprint, and firm-wide investment in privacy as a strategic area of growth. Requirements Deep subject matter expertise in domestic and global privacy laws (GDPR, CCPA/CPRA, HIPAA, GLBA, FERPA, and others) Demonstrated ability to lead client relationships and provide strategic advice on privacy compliance, operational implementation, and risk mitigation Experience supporting incident response, breach notification, and regulatory investigations Familiarity with privacy due diligence and data-related concerns in M&A and commercial transactions Strong skills in drafting and negotiating data protection agreements, vendor and customer contracts, and privacy schedules A client-first mindset, strong judgment, and a collaborative, solutions-oriented approach A portable book of business is welcomed but not required Benefits Medical, dental, and vision insurance Life and disability coverage Flexible spending accounts and commuter benefits Generous vacation and sick leave Paid holidays, parental leave, fertility benefits, and backup care support

Carlstadt, NJ, USA

$225,000-250,000/year

Hybrid Senior Associate Level Privacy Law63499976623105123

Workable

Hybrid Senior Associate Level Privacy Law

Hybrid Law Firm Senior Associate Privacy Salary Range of 150K-210K Plus Yearly Bonus Offered Excellent compensation package plus benefits Bergen County, NJ A nationally recognized law firm is seeking a seasoned Privacy and Data Protection Partner to help expand a rapidly growing Privacy and Data Protection Practice. This strategic hire will support increasing client demand and strengthen the team’s ability to counsel sophisticated clients on complex and evolving data privacy issues. About the Role: The ideal candidate will bring extensive experience advising clients on U.S. and international privacy laws and frameworks, providing practical and forward-thinking legal guidance on compliance, risk management, incident response, and strategic data use. You’ll serve clients across industries such as technology, healthcare, education, media, retail, and financial services. In this role, you’ll collaborate closely with other senior attorneys and practice leaders, mentor junior lawyers, contribute to thought leadership, and play a key role in expanding one of the firm’s fastest-growing practices. Why Join: This opportunity offers a national platform and entrepreneurial environment where experienced attorneys can lead and grow. The Privacy and Data Protection team is collaborative and interdisciplinary, working closely with practices across corporate, employment, healthcare, and IP law. Attorneys are supported by strong administrative resources, a national footprint, and firm-wide investment in privacy as a strategic area of growth. Requirements Deep subject matter expertise in domestic and global privacy laws (GDPR, CCPA/CPRA, HIPAA, GLBA, FERPA, and others) Demonstrated ability to lead client relationships and provide strategic advice on privacy compliance, operational implementation, and risk mitigation Experience supporting incident response, breach notification, and regulatory investigations Familiarity with privacy due diligence and data-related concerns in M&A and commercial transactions Strong skills in drafting and negotiating data protection agreements, vendor and customer contracts, and privacy schedules A client-first mindset, strong judgment, and a collaborative, solutions-oriented approach A portable book of business is welcomed but not required Benefits Medical, dental, and vision insurance Life and disability coverage Flexible spending accounts and commuter benefits Generous vacation and sick leave Paid holidays, parental leave, fertility benefits, and backup care support

Carlstadt, NJ, USA

$150,000-210,000/year

Senior Manager Regulatory Affairs, Advertising and Promotion - Job ID: 169063499972131201124

Workable

Senior Manager Regulatory Affairs, Advertising and Promotion - Job ID: 1690

At Ascendis, we strive to make meaningful improvements in patients’ lives. We make business decisions on patient’s needs and we do our best every day to realize our products’ benefits for our patients. We are driven by patients, science, and data. We are dedicated to being curious and diligent when innovating, developing, and improving products and processes. We are passionate about realizing our shared vision and goals. We trust each other’s strengths, and when we face challenges, we remain optimistic and committed to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an internal expert on U.S. FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in a compliant manner. As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs, Advertising and Promotion. There is a preference for this position to work out of our Princeton, NJ. This position will primarily support stakeholders working East Coast hours. Key Responsibilities Review/approve promotional, medical, payor, corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies/best practices Collaborate with Medical, Legal, Commercial, and Compliance to execute and approve key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk. Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents. Assumes a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts, target, or product labeling, and to provide strategic regulatory guidance on corporate communications and appropriate pre-approval and/or disease education communications Serve as the company's regulatory liaison to the FDA’s Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion for respective product(s) and will ensure materials are submitted to FDA via 2253. Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues. Requirements Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred. Minimum of 7 years of experience in Regulatory Affairs promotion and advertising working with prescription drug, biologic, and/or combination products; experience managing major regulatory filing(s) to the FDA Office of Prescription Drug Promotion (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints. Launch experience is a plus. Understand the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions. Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion. Knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders. Extensive experience within relevant Therapeutic Area Extensive experience in managing complex negotiations with internal as well as external stakeholders Demonstrated leadership skills. Ability to manage and bring working teams together for common objectives. Excellent oral and written skills, timeline responsibilities. Prior experience with an EDMS required, preferably Veeva Promomats and RIM. Ability to travel to various meetings including overnight trips. Some international travel may be required. Requires up to 20% travel. Salary Range: $170-185k DOE Benefits 401(k) plan with company match Medical, dental, and vision plans Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of Pet Insurance and Legal Insurance Employee Assistance Program Employee Discounts Professional Development Health Saving Account (HSA) Flexible Spending Accounts Various incentive compensation plans Accident, Critical Illness, and Hospital Indemnity Insurance Mental Health resources Paid leave benefits for new parents A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Princeton, NJ, USA

$170,000-185,000/year