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Author, review and provide input and approval for drug-safety related regulatory reports and clinical study documents including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package and labeling. Investigate and review emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports, published literature, aggregate reports, toxicology reports, non-clinical studies, and other source.

Insmed

Associate Director, Pharmacovigilance/Product Safety

Analyze supplier quality data and performance trends, including deviations, CAPAs, audit findings, inspection outcomes, data integrity issues, and timeliness metrics, and facilitate, in collaboration with functional representative supplier governance forums and business reviews to drive remediation actions, corrective measures, and continuous improvement while maintaining accurate supplier records and approved supplier listings. Partner with DevQA to develop, manage, and continuously improve supplier performance monitoring frameworks for clinical suppliers in collaboration with the functional representatives, including KPIs, scorecards, and quality metrics, ensuring accurate risk-based scoring, timely completion, and appropriate control alignment.

Senior Manager, Clinical Supplier Quality

As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. You’ll also: Assist in designing and developing a QA Metrics Dashboard to improve visibility into quality metrics and operational performance Analyze and compare quality systems across multiple CMOs.

Summer Intern – CMC Quality Assurance, Clinical Programs

Provide proactive legal advice to business partners and drive legal strategy through the review of brand team initiatives in support of execution of brand plan for one of Insmed’s marketed respiratory products in accordance with current FDA and FTC regulations, guidance, and enforcement activities with a focus on anti-kickback, false claims act, and advertising and promotional regulations, and counsel on risk mitigation strategies, as needed. Identify, communicate, and provide updates to business partners and the legal team on risks associated with day-to-day operational business activities and on current federal and state legal, regulatory, and enforcement developments related to the life sciences industry, including training clients on applicable legal issues within your expertise.

Director, Brand Counsel

Enable Medical Affairs Teams with data, tools, and models to inform prioritization of activity and planning (i.e. channel engagement, ME identification and segmentation, etc ) Drive ad-hoc analyses to support Medical Affairs strategic understanding to enable launch preparation and success. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.

Director Medical Insights & Analytics

You’ll have responsibility for the management of API/Intermediate/RSM manufacturing at Insmed’s CMOs including synthesis route and early-stage process identification, tech transfer, process optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.

Director, Process Chemistry

Building on our publishing heritage, we combine quality information and vast data sets with analytics to support visionary science and research, health education and interactive learning, as well as exceptional healthcare and clinical practice. If performed in Maryland, the base pay range is $121,200 - $201,900.If performed in New Jersey, the base pay range is $136,213 - $217,587.If performed in Ohio, the base pay range is $109,500 - $182,700.

YEAR

RELX Group plc

Sr Accessibility Product Manager, Clinical Solutions (Remote)

As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. Process Development & Optimization : Design, develop, and optimize manufacturing processes for pharmaceutical APIs and formulations; with an emphasis on particle engineering via spray drying and low fill weight powder encapsulation.

Manager, Contract Manufacturing

Work with the DSPV leadership to develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products. Reporting to the Sr Director, DSPV Gene Therapy Safety Lead, the Director, Medical Safety Lead serves as the DSPV subject matter expert for assigned products, maintaining deep and up-to-date knowledge of the product portfolio and associated safety profiles.

Director, Medical Safety Lead - DSPV, Gene Therapy

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. Requirements • Communication that is clear and human • Discipline without a supervisor in the hallway • Openness to a proven process • Interest in benefits conversations, not just “sales energy” .

AO Garcia Agency

Virtual Appointment Coordinator

Reporting to the Medical Affairs Leadership, you’ll develop and maintain professional relationships with external healthcare practitioners, deliver comprehensive medical and scientific support across PAH, IPF, and PPF, and serve as a trusted field-based expert connecting HCP insights with Insmed’s research and commercial strategy. Effective presentation skills and advanced proficiency in interpersonal skills (listening, probing, persuasiveness, negotiation) are essential for engaging successfully and productively with HCPs, external customers, field colleagues, and internal partners.

Associate Director, Medical Science Liaison - Michigan, Indiana

Trend performance, deviations, CAPAs, audit findings, inspection observations, and other quality indicators to identify recurring issues and systemic risks and communicate insights on PV system effectiveness to DSPV leadership and governance forums. Reporting to the VP, Global Head of DSPV, the Senior Director will be responsible for oversight of the Drug Safety and Pharmacovigilance (DSPV) quality and compliance framework, supporting the ongoing effectiveness, inspection readiness, and regulatory compliance of the PV function.

Senior Director, DSPV Quality, Training & Compliance

Serve as the Global Regulatory Lead and senior regulatory representative on GPTs, providing strategic regulatory guidance and influencing key development decisions, including indication strategy, development pathways, clinical program design, endpoints, patient populations, evidence requirements, and registration strategy. As the senior regulatory representative on Global Program Teams (GPTs), the GRL will provide strategic regulatory leadership to cross-functional decision-making and ensure alignment of regulatory strategy with clinical, nonclinical, CMC, safety, commercial, and other development objectives.

Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy

Reporting to the Global Commercial Lead, you'll coordinate the commercial U.S. expert leader strategy, drive awareness among the HCP community, and lead regional marketing across Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), Idiopathic Pulmonary Fibrosis (IPF), and Progressive Pulmonary Fibrosis (PPF). You have a minimum Bachelor's degree (MBA or advanced degree preferred) along with 8–10+ years of experience in pharmaceutical/biotech commercial roles, including 5+ years in U.S. regional marketing, sales, and HCP/expert engagement , or a combination of education, training, and experience.

Director, Marketing – Expert Engagement & Regional Marketing

Entry-Level Remote Financial Services Associate

Reporting to the Senior Director, Regulatory Affairs CMC, EMEA, you’ll have responsibility for leading CMC regulatory strategy development and implementation that incorporates risk identification and mitigation for assigned development and post approval programs to achieve regulatory approvals in the EMEA region. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.

Associate Director, Regulatory Affairs (CMC)

You have a minimum Bachelor's degree in Data Science, Business Analytics, Economics, Engineering, or a related field, along with 8+ years of progressive experience in pharmaceutical or biotech Commercial analytics, data strategy, and advanced analytics related roles, or a combination of education, training, and experience. Partner with Brand, Marketing, Field Strategy & Operations, and Commercial leadership to understand key business challenges and introduce data innovation opportunities, extending successful initiatives across the organization where broader value exists.

Director, Data Innovation & Strategy

As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.

Senior Manager, Biostatistics

As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. You’ll have responsibility for the management of API/Intermediate/RSM manufacturing at Insmed’s CMOs including tech transfer, process optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy.

Senior Manager, Process Chemistry

Second, the role supports cross-functional discussions with Insmed discovery research platforms as molecules advance beyond the Late Lead Optimization milestone that may have potential development in immunological disorders apart from respiratory diseases and as cush there is an expectation that the physician will possess sufficient breadth of experience to contribute meaningfully to initial evaluations across multiple immunological disorders; leveraging external medical experts as needed. Drug development experiences will be considered as relevant, along with at least 7 years of clinical development experience in biotech or pharmaceutical settings, with meaningful drug development experience across modalities, including oral small molecules and biologics; experience with combination drug–device products preferred.

Work From Home Jobs in New Jersey

Associate Director, Pharmacovigilance/Product Safety Insmed

Senior Manager, Clinical Supplier Quality Insmed

Summer Intern – CMC Quality Assurance, Clinical Programs Insmed

Director, Brand Counsel Insmed

Director Medical Insights & Analytics Insmed

Director, Process Chemistry Insmed

Sr Accessibility Product Manager, Clinical Solutions (Remote) RELX Group plc

Manager, Contract Manufacturing Insmed

Director, Medical Safety Lead - DSPV, Gene Therapy Insmed

Virtual Appointment Coordinator AO Garcia Agency

Associate Director, Medical Science Liaison - Michigan, Indiana Insmed

Senior Director, DSPV Quality, Training & Compliance Insmed

Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy Insmed

Director, Marketing – Expert Engagement & Regional Marketing Insmed

Entry-Level Remote Financial Services Associate AO Garcia Agency

Associate Director, Regulatory Affairs (CMC) Insmed

Director, Data Innovation & Strategy Insmed

Senior Manager, Biostatistics Insmed

Senior Manager, Process Chemistry Insmed

Senior Director, Clinical Development Insmed

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