Senior Medical Writer - Regulatory Submissions & Strategy
Artech Information Systems LLC
A leading staffing solutions firm in New Jersey is seeking a professional to create documents necessary for clinical data management and regulatory submissions. The ideal candidate will possess excellent scientific writing and analytical skills, managing deadlines and ensuring compliance with regulatory standards. You will lead document strategies and collaborate with project teams to deliver high-quality documents effectively. Strong interpersonal skills and familiarity with global regulatory guidance are essential for success in this role. #J-18808-Ljbffr
- A leading staffing firm is seeking a Medical Author to document clinical data and regulatory submissions to support drug development. This role requires expertise in analytical writing, project management, and collaboration with product teams to ensure high-quality deliverables...SeniorRegulatory
- ...Shionogi Inc. (U.S.) is seeking a Senior Manager/Associate Director, Regulatory Affairs CMC to define and execute global CMC regulatory strategies for investigational and/or marketed assets... ...supply and program teams to deliver submission-ready CMC content with a risk-based...SeniorRegulatory
- ...lead for oncology programs to partner with development medical leads and set safety strategy across the product lifecycle, including surveillance... ...in pharmacovigilance or clinical development, plus regulatory submission support and strong cross-functional leadership. #J-1...SeniorRegulatory
- ...Precision Medicine Group is seeking a Senior Medical Writer to develop medically accurate content for our pharmaceutical clients, working with... ...is achieved and content is aligned with scientific and regulatory standards. You will mentor junior staff, conduct literature...SeniorRegulatory
- ...Job Title Senior Manager, Patient Access Strategy & Operations Requisition JR000016053 Senior Manager, Patient Access Strategy & Operations (Open)... ...with department leadership to connect with Legal and Regulatory to ensure compliant functioning of all program operations...SeniorRegulatoryContract work
- ...documents to support meetings with regulatory agencies, clinical documents... ...documents for regulatory submission. Provide project teams with... ...proposes or contributes to strategies to resolve any identified... ...clinical data, reviews of the medical literature, and similar...RegulatoryFor contractorsImmediate start
$75k - $112.5k
...clinical, and societal value of creative medical treatments to payers, providers,... ...around the world. Position Summary The Senior Medical Writer is responsible for developing and writing... ...as necessary Attend medical, legal, regulatory review meetings and participate, as...SeniorRegulatory- ...health issues today and address the medical challenges of tomorrow. We... .... Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada is responsible for the... ...preparation and review of regulatory submissions consistent within US and Canada...SeniorRegulatoryWork at officeRemote work
$202.4k - $304.8k
...The Senior Operational Strategy Director will be a core member of the expert team within Operational... ...not limited to: Collaborate with medical, operational, business development, proposal... ...Precision for Medicine’s SOPs and regulatory guidance. Ability to work as part...SeniorRegulatoryNight shift- ...Altimmune in Morristown, NJ is seeking a Senior Director to lead drug substance development and manufacturing strategy for peptide APIs, interfacing with external CDMOs and internal Quality, Regulatory, and program teams. The role requires 10+ years in industry and...SeniorRegulatory
- ...Description- • The Author will provide medical documentation summarizing risks and... ...safety and efficacy, responses to regulatory questions, risk management plans,... ...complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team...RegulatoryFor contractors
- ...healthcare leader, seeks an Associate Director, Regulatory Writing to produce high-quality regulatory... ...across functions and focuses on BLA/MAA submissions, CSRs, and briefing books while managing information flow and strategy. The candidate will contribute scientific insights...SeniorRegulatoryRemote work
$280.35k
...project/product risk management strategies aimed at achieving the... ...with Clinical Development, Regulatory, Project Management, Biostatistics... ...of the compound, lead and medical-scientifically direct a team... ...in clinical development, submission and post marketing, is strongly...SeniorRegulatory- ...Director, Clinical Supply Management to lead the US Medical Affairs CSM team. You will develop drug supply strategy and tactical approaches for Sponsored, IITs,... ...supply risks, optimize forecasting, and ensure regulatory compliance, quality and cost controls, #J-18808...SeniorRegulatory
$280.35k
...society.Job SummaryThe Senior Director sits within... ...dedicated to the effective strategy, design, execution,... ...a primary source of medical accountability and oversight... ...(e.g., CSR, IB, regulatory responses)Interprets and... ..., such as pre-submissions, end of phase 1/2, and...SeniorRegulatory$109k - $174.8k
...Information Job Function: Medical Affairs Group Job Sub Function... ...best talent for a Medical Writer III, Regulatory Medical Writing to support... ...be considered as a single submission. You Will Be Responsible For... ...establishing document timelines and strategies in accordance with internal...RegulatoryLocal areaRemote work- ...Daiichi Sankyo US in New Jersey seeks a Global Regulatory Lead to shape regulatory strategy for development programs and represent regulatory in GPT meetings. You will guide submissions, align regional plans, and ensure Health Authority alignment across global programs...Regulatory
- Sanofi is seeking a Senior Statistical Project Leader to lead statistics strategy for oncology trials in a hybrid model across Cambridge, MA and Morristown, NJ.... ...leadership in study design, analysis plans, and regulatory interactions, guiding cross-functional teams and...SeniorRegulatory
$280.35k
...families, and society.Job SummaryThe Senior Director, Early Clinical Development role... ...the creation of developmental and regulatory strategy; Accountable for performance of CROs;... ...protocol profiles and sections of key submission documents; Represents Clinical Development...SeniorRegulatory- ...Senior Manager Regulatory Affairs position focused on developing and executing US and Canada regulatory strategies for marketed and developmental products. Responsibilities include FDA liaison activities, regulatory submission preparation, and cross-functional coordination...SeniorRegulatory
$105.4k - $207.8k
Position Summary Cyber Security & Risk Strategy Senior Consultant Our Deloitte Cyber team understands the unique challenges and opportunities... ...programs in line with a client's strategic objectives, regulatory requirements, and risk appetite. It keeps the enterprise a...SeniorRegulatoryLocal areaVisa sponsorship$189.2k - $372.9k
Position Summary Private Equity M&A Strategy & Diligence Senior ManagerOur Deloitte Strategy & Transactions team helps guide clients through... ...to address a range of critical issues brought on by regulatory changes, competition, globalization, advances in technology...SeniorRegulatoryOdd jobWork experience placementLocal area$150k - $185k
...Senior Manager, Contracts & Pricing Strategy The salary range for this position is between $150K and $185K. Actual salary at the time of hire may... ...Monitor market dynamics, competitive activity, and regulatory developments to assess business impact and support strategic...SeniorRegulatoryContract workNight shift- ...focus of the Novartis corporate strategy. This role will be... ...application, and the changing regulatory landscape. Ensure all tax... ...effectively relate tax issues to senior leadership; demonstrated understanding... ...at the intersection of medical science and digital innovation...SeniorRegulatoryFull timeLocal areaShift work
- .... About the role The SVP, Brand Strategy is a senior leader responsible for setting the strategic... ...with Creative, Account, Experience, Medical, and Analytics teams to deliver... ...and grounded in real‑world brand and regulatory constraints. Lead and develop a team...SeniorRegulatory
- ...resilient. You Are:Our AI and Data Strategy practitioners work to create... ...:As an AI & Data Strategy Senior Manager, you will:Shape... ...finance, controllership, or regulatory function.Bachelor's degree or... ...suite of benefits including medical, dental, vision, life, and long...SeniorRegulatoryWork experience placementLive inWork at officeLocal area
$100k - $230k
...About the RoleWe are looking for a creatively driven integrated Medical Strategy professional to work across a portfolio of well-known... ...deliverableWorking knowledge of clinical or preclinical research principles, regulatory affairs, and biostatisticsLine management history...SeniorRegulatory$183.5k - $352k
...Director - Business Development and Strategy is a key leadership position... ..., Sourcing, Real Estate, Regulatory, and Product.Performance... ...functions.What we're looking for...Seniority: 10+ years of relevant... ...wellness benefit options including: medical, dental, vision, short and...SeniorRegulatoryFull timeTemporary workPart timeWork at officeWork from homeFlexible hoursShift work3 days per week$170k - $190k
The Senior Clinical Trial Drug Supply Manager is a critical position within the clinical... ...the execution of clinical trials and regulatory submissions. This role will be responsible for... ...distribution and expiry date management strategies. This position provide cross-...SeniorRegulatoryTemporary workWork at officeFlexible hours- ...Staffing Solutions is recruiting a Senior Associate - Regulatory Tax for an established organization... ...: Manage state and local regulatory submissions, including video franchise fees, Public... ...taxation, and tax-saving strategies. Working knowledge of financial reporting...SeniorRegulatoryFull timeContract workLocal areaRemote workRelocation
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