Regulatory Medical Writer: FDA Submissions Lead
Immix Biopharma (Nasdaq: IMMX)
A biopharmaceutical company seeks a Regulatory Medical Writer in Los Angeles, CA. This role involves preparing, reviewing, and editing regulatory documents for submission to the FDA, ensuring compliance with guidelines. Required qualifications include a Bachelor’s degree in a relevant field and at least 5 years of experience in regulatory writing. Strong communication skills and a detail-oriented approach are essential. Join a dynamic team dedicated to advancing biopharmaceutical products through clinical trials. #J-18808-Ljbffr Immix Biopharma (Nasdaq: IMMX)
$145k - $155k
Terumo Group is seeking a Sr. Medical Writer for a remote role in Los Angeles. This position involves collaborating with clinical and regulatory teams to produce a range of medical documents for regulatory submissions, including clinical evaluation reports and study protocols...RegulatoryRemote job- The Regulatory Medical Writer will play a critical role in the clinical development department, responsible for preparing... ...and editing regulatory documents required for submission to the U.S. Food and Drug Administration (FDA) and other regulatory bodies. This position...Regulatory
$145k - $155k
Sr. Medical Writer Peripheral Vascular Med Device (U.S. Remote) Position Overview This is a Temp-To-Hire... ...include: Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to: Clinical evaluation...RegulatoryRemote jobTemporary workInterim role- Kite Pharma seeks a Senior Director of Regulatory CMC for CAR T Cell Therapy to lead global regulatory activities for CMC. This position requires substantial... ...leader, you will set regulatory strategies, manage submissions, and mentor teams while ensuring compliance and...RegulatoryFlexible hours
- ...Open Position - Program Lead Horizon Surgical... ...complex, cross-functional medical device programs. In this... ...quality, clinical, and regulatory functions, coordinating... ..., and regulatory submission. ~ Deep fluency with... ...Experience with FDA design controls, stage-...RegulatoryRemote workRelocation
- Lead Biostatistician - FDA BLA Submission (Clinical Trial Statistical Design) This is an exciting opportunity to lead our global Biostatistics efforts. Clinical Trial Statistical Design and BLA Submission Draft accurate, clear and detailed statistical analysis plans (...
- Immix Biopharma (Nasdaq: IMMX) is looking for a Lead Biostatistician to oversee global biostatistics efforts. This role involves... ...statistical analysis plans, working with clinical trial data for FDA submissions, and utilizing statistical software like SAS and R. Ideal...
- Nexcella, Inc. is looking for a Lead Biostatistician to lead their global Biostatistics efforts in FDA BLA submissions. The candidate should have a Ph.D., Master's, or Bachelor's degree in Biostatistics or a related field and multi-year experience in clinical trial statistical...
- Flourish Research is seeking a Regional Regulatory Specialist for our Northridge, CA site. You will prepare and oversee research-related regulatory documents and manage submissions to IRBs and regulatory agencies. We are looking for detail-oriented candidates with a high...RegulatoryHourly pay
$70k - $80k
...Risk Analyst Lead Location: Los Angeles, CA Job Type... ...industry rules, trends, and regulatory changes. Essential Duties... ...Competitive employer contribution to medical, dental and vision coverage... ...in place, no agency submissions will be accepted or compensated...RegulatoryFull timeWork at officeLocal areaRemote workFlexible hours- ...healthcare solutions firm is seeking a Medical Information Specialist to support day-to... ...role includes managing content submissions and coordinating Medical Review Committee... ...Committee activities, ensuring compliance with regulatory standards. The ideal candidate will...RegulatoryContract work
$30 per hour
...; meets with incoming shift Lead(s) to discuss prior to leaving... ..., reviewing IPPs and IBSPs, medication administration records (MARs... ...ensure appropriate billing submissions. Serves as Facility... ...State, Local and other relevant regulatory agency requirements, including...RegulatoryLocal areaImmediate startShift work- ...and empowering individuals to lead healthier lives, apply now to... ...adherence (including medication), and provides health promotion... ...other reports as assigned for submission to the funding source. # Participates... ...policies, procedures, and regulatory requirements to ensure a safe...RegulatoryTemporary workWork at office
$105k - $125k
...Manager responsible for managing quality projects related to FDA submissions and leading cross-functional teams. The ideal candidate should possess... ...a minimum of 5 years’ experience in the pharmaceutical or medical device industry. This role involves developing project...$120k - $160k
JPI Employment Services, LLC is looking for a Permit Lead to manage the permit acquisition and compliance coordination for various... ...internal teams, ensuring timely approvals and clear interpretation of regulatory mandates. The ideal candidate will have a degree in...Regulatory- ...looking for a Compliance Manager in Santa Fe Springs, California. The role involves leading compliance initiatives for products sold in North America, ensuring they meet all regulatory requirements. Ideal candidates will have over 6 years of experience in compliance within...Regulatory
- A leading cosmetics company is seeking a Senior Manager, Regulatory Strategy to ensure compliance with regulations and optimize product development. This role includes developing regulatory strategies, overseeing product compliance, and managing a team of regulatory professionals...Regulatory
$94.2k - $141.2k
Northrop Grumman Corp. is seeking a Principal Regulatory Compliance Analyst in Los Angeles, CA. The role involves ensuring compliance with regulatory requirements impacting the Estimating System, developing impactful training initiatives, and addressing compliance questions...Regulatory- An established industry player in food solutions is seeking a skilled Regulatory Affairs Specialist to ensure compliance and safety of products. This permanent role offers a chance to shape industry standards while collaborating with cross-functional teams. You will oversee...RegulatoryPermanent employment
- A leading AI technology company is seeking a Senior Legal Program Manager in San Francisco to lead global compliance for hardware launches. This role involves managing regulatory requirements and ensuring products meet legal obligations. Candidates should have over 8 years...Regulatory
$110k - $135k
A leading global food and beverage company in Los Angeles seeks a Global Regulatory Manager to ensure compliance and guide product development. The role requires extensive experience in regulatory affairs, knowledge of FDA laws, and strong communication skills. This position...Regulatory- ...seeking a Workplace Operations Specialist to enhance and manage workplace operations, ensuring timely preventive maintenance and regulatory compliance. In this role, you will work closely with internal teams and vendors, oversee work requests, and conduct facility inspections...Regulatory
$133.3k - $183.3k
...within the Information Security team. The role involves managing a team of compliance analysts and ensuring the IT environment meets regulatory requirements. The ideal candidate will have 7+ years of relevant experience, strong leadership skills, and a deep understanding...RegulatoryFull time$114.4k - $171.6k
...regulations, change management, and compliance, with a focus on the medical device industry. The ideal candidate will coordinate audits, support cross-functional teams, and ensure alignment with regulatory expectations. The position offers a competitive salary range of...Regulatory- A leading food manufacturing company is seeking a remote Quality Partnership Manager to ensure product quality and regulatory compliance across various partners. The role involves conducting audits, maintaining partnerships, and overseeing quality systems. Ideal candidates...RegulatoryRemote job
- ...healthcare systems. This remote role requires extensive healthcare and coding experience, along with leadership skills in maintaining regulatory standards and resolution of billing issues. Candidates must have at least an Associate's Degree and specific certifications...RegulatoryRemote job
$200k - $250k
...Risk Lead The Risk Lead will direct the TCW's Portfolio Risk Management function within the Investment Risk & Quantitative Research... ...through established protocols. Ensure compliance with regulatory requirements and client mandates. Team Management :...Regulatory- Faraday Future in Los Angeles is seeking a Lead Capital Markets Associate to oversee full cycle execution of financing transactions... ...communication about the company’s financial performance and ensure regulatory compliance while managing diverse stakeholder relationships....Regulatory
- ...Contracts And Pricing Strategy Lead Northwood is on a mission to transform connectivity between earth and space and bring the benefits... ...and pricing approaches that align customer requirements, regulatory constraints, and Northwood's business goals Shape acquisition...RegulatoryPermanent employmentContract work
$71k - $96k
...Materials Lead Los Angeles, California Open Position – Materials Lead Horizon... ...Horizon Surgical Systems is an innovative medical device startup developing the first ever... ...manufacturing and prepare for clinical and regulatory milestones. We are seeking a highly...Regulatory
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