Director of Medical Writing — Global Regulatory Submissions
Incyte Corporation
Incyte Corporation in Wilmington, Delaware, seeks an accomplished Director of Medical Writing to lead medical writing across a portfolio of oncology/hematology programs. You will oversee regulatory documents (IBs, CSRs, submission dossiers), provide leadership to writers, ensure timely, scientifically rigorous data presentation, and align with global regulatory standards. Reporting to the Head of Medical Writing, you will manage resources, escalate issues, guide SOPs, and contribute to MW #J-18808-Ljbffr Incyte Corporation
- Overview A global biopharmaceutical company on... ...patients with unmet medical needs. Through the discovery... ...function) The Director, Medical Writing is responsible for... ...marketing authorization submission documents)... ...with program goals and regulatory requirements. Writes...MedicalRegulatoryContract workWork experience placement
$137.94k - $206.91k
...Local Study Associate Director) Location: Field At AstraZeneca... ...in alignment with Global Study Team (GST), for... ...risk. Ensure timely submission of required... ..., in partnership with Regulatory Affairs, support the delivery... ...Collaborate with the local Medical Affairs team as needed...MedicalRegulatoryHourly payTemporary workLocal areaWorldwideFlexible hours$142.4k - $224.1k
...Description The Associate Director for Drug Product... ...talent from our Company global team and the biotechnology... ...Company policies and regulatory requirements will also... ...of regulatory submissions, inspection readiness... ...Available benefits include medical, dental, vision healthcare...MedicalRegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- .... Reporting directly to the Executive Director, US Medical Early Asset Team Lead, you will be part... .... You will influence across a complex global matrix to ensure US payer, health-... ...Clinical Development, Medical, HEOR, Regulatory, Commercial, Finance, Policy, and global...MedicalRegulatoryContract workWork at officeWorldwideFlexible hours3 days per week
- Merck & Co., Inc. is seeking an Associate Director for Drug Product Quality Assurance to... ...Delaware. The role emphasizes cGMP compliance, regulatory requirements, and building a robust QA... ...readiness, while partnering with global teams to ensure quality and compliance...Regulatory
- Director, US Policy Evidence Location: Wilmington, DE About AstraZeneca AstraZeneca is a global, innovation-driven BioPharmaceuticals business that... ...role within the US Medical Affairs, Implementation Science... ...evolving US legislative, regulatory, and reimbursement...MedicalRegulatoryHourly payTemporary work
- Incyte, a global biopharmaceutical company headquartered in Wilmington, DE, seeks a Senior Director of Global R&D and Clinical Compliance to lead... ...across R&D, Clinical, Medical Affairs, and Technical Operations... ...leadership to ensure regulatory readiness and robust...MedicalRegulatory
- Associate Director, NPPA, Thought Leader Liaison, Immunology - West A global biopharmaceutical company on a mission to Solve On... ...solutions for patients with unmet medical needs. Through the discovery,... ...applicable company policies, regulatory requirements and industry...MedicalRegulatoryWork at officeNight shift
$65k - $90k
...marketing agency, supports global pharmaceutical and life sciences... ...next steps. Facilitate the medical-legal-regulatory review process to ensure... ...) review Experience in writing SOWs and project briefs Hands... ...experience with clients' on-line submission systems (e.g. Zinc or Veeva...MedicalRegulatoryWork at officeFlexible hours- ...We are looking for a Regulatory Affairs Leader to join... ...achieving and maintaining global marketing approvals or... ...comprehensive global submission planning. This is a... ...Regulatory function and Gore Medical by facilitating... ...strategy, and submission writing Experience with...MedicalRegulatoryRemote workWork from homeShift work
- CSC is a global business, legal, and financial services company based in Wilmington, Delaware, USA, providing knowledge-based solutions... ...delivery across regions, balancing global standards with local regulatory and cultural requirements. , By modernizing service delivery...RegulatoryLocal areaWorldwide
- ...Hospital Delaware by assisting in regulatory document preparation and... ...and assent documents for submission to IRB. Coordinates IRB submissions... ...in the maintenance of study medication accountability records;... ...verbally and in writing Source: AAHKS Job Board · Imported...MedicalRegulatoryFull time
- Job Description Nemours is seeking a Sr. Director, Compensation. Serves as the enterprise-... ...(e.g., pay equity, pay transparency, regulatory changes, competitive labor dynamics). Compensation... ...patient encounters annually, we provide medical care in five states through two...MedicalRegulatoryTemporary workLocal area
- AstraZeneca in Wilmington seeks an Associate Director, Marketing to lead launch brand strategy across US HCP and patient promotion... .... You will partner with cross-functional teams—Sales, Regulatory, Access, Medical—and manage agencies, budgets, and omnichannel campaigns...MedicalRegulatory
- ...are seeking a highly skilled Director, HRIS with deep expertise in... ...technology initiatives and manage a global HRIS team. This role will be... ...security, governance, and regulatory requirements related to HRIS.... ...childbirth and related medical conditions), genetic information...MedicalRegulatoryLocal area3 days per week
- Overview A global biopharmaceutical company on a mission to Solve... ...solutions for patients with unmet medical needs. Through the discovery,... ..., and Asia. The Associate Director, Sales Training - Hematology/... ...the Medical, Legal and Regulatory review process. Facilitate live...MedicalRegulatory
- Overview A global biopharmaceutical company on a mission to Solve On, Incyte follows science... ...find solutions for patients with unmet medical needs. Through the discovery,... ...workstream across Commercial, Market Access, Regulatory, Insights & Analytics, Sales, Training,...MedicalRegulatoryEarly shift
- ...medicine and bring big new ideas to life. Join us as Associate Director, Marketing in Wilmington for the New CVRM Franchise where... ...other marketing peers across consumer/HCP, Corporate Affairs, Medical, Regulatory and Access partners. Your role will also involve leading...MedicalRegulatoryRelocation package
- Overview A global biopharmaceutical company on a mission to Solve On, Incyte follows science... ...find solutions for patients with unmet medical needs. Through the discovery,... ...highly preferred, including familiarity with regulatory and compliance standards. Consultative Skills...MedicalRegulatory
$173.2k - $272.6k
Job Summary The QMS Global Quality Compliance Director reports into the Associate Vice President, Global QMS... ...Metrics, Quality Risk Management, Regulatory Compliance {+ 3 more} US And Puerto... ...benefits. Available benefits include medical, dental, vision healthcare and other...MedicalRegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Overview A global biopharmaceutical company on a mission to Solve... ...solutions for patients with unmet medical needs. Through the discovery,... ..., and Asia. The Associate Director, Patient Service Center (PSC)... ...operational excellence, regulatory compliance, and continuous improvement...MedicalRegulatoryWork at office
- Overview A global biopharmaceutical company on a mission to Solve On, Incyte follows science... ...find solutions for patients with unmet medical needs. Through the discovery,... ..., and alignment with brand strategy and regulatory guidance. Plan advisory boards (live and...MedicalRegulatoryWork experience placementWork at office
- Incyte Corporation, a global biopharmaceutical company headquartered... ..., Delaware, seeks a Senior Director, Global R&D and Clinical... ...adherence to GCP, privacy laws, and regulatory requirements worldwide. You... ...to align controls with submissions and #J-18808-Ljbffr Incyte...RegulatoryWorldwide
$112.88k - $165.53k
...federal, state, and local employment laws, regulatory requirements, and internal policies. As... ...effectively, both verbally and in writing, with clients, lawyers, business professionals... ...package of benefits including medical/dental/vision insurance, and 401(k). Applicants...RegulatoryWork at officeLocal areaRemote workRelocationVisa sponsorshipRelocation package- Associate Director, US Lifecycle Marketing - Immunology Location: Wilmington, DE (3 days... ...progression of assets through MLR, Legal, and Regulatory review, enabling compliant, on‑label,... ...leaves; and health benefits including medical, prescription drug, dental, and vision coverage...MedicalRegulatoryHourly payTemporary workFlexible hours3 days per week
$22.61 - $37.67 per hour
Overview Assists with limited aspects of Global Capital Markets trust or entity... ...Understand and adhere to the Company’s risk and regulatory standards, policies and controls in accordance... ...competitive benefits ranging from medical and retirement to forty hours of paid volunteer...MedicalRegulatoryHourly payWork experience placementLocal areaImmediate start- ...Medical Oncology Hematology Consultants, Newark, DE We are a private practice comprised of 17 physicians and 12 APPs. Our mission... ...administrator, or researcher. Ensures compliance with OSHA and other regulatory standards and requirements. Supports and adheres to the US...MedicalRegulatoryPrivate practiceLocal area
$200.95k - $401.89k
...lead to the same place. The Global Controller leads the firm’s... ..., compliance with applicable regulatory requirements, and the effectiveness... ...Partner with CFO, Director of Financial Planning & Analysis... ...-time personnel include: ~ Medical/Prescription Drug Coverage (including...MedicalRegulatoryFull timeTemporary workWork at officeLocal areaRemote workWorldwideRelocationFlexible hours$197.39k - $296.09k
...week onsite The Senior Director, US Scientific... ...defines the overall US medical content development strategy... ...and Therapy Areas teams, Global Scientific Communications, Promotional Regulatory Affairs, Legal, Compliance... ...enquiry management and writing medical content....MedicalRegulatoryTemporary workWork at officeLocal areaFlexible hours3 days per week- ...AstraZeneca seeks a strategic Director to lead policy evidence generation and dissemination across US Medical Affairs. The role develops frameworks connecting clinical... ...research Deep expertise in US legislative, regulatory, and reimbursement landscape Strong...MedicalRegulatory
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