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- ...Managerial experience (Dermatology a plus) Computer Skills - Microsoft Office Suite that includes, Word, Excel, PowerPoint and Teams. EMA, and Laboratory Information Systems and Time Management System. The ability to learn new computer programs. Salary Description...SuggestedDaily paidFull timeWork at office
Advanced Dermatology
Remote8 hours ago $135k - $200k
...Who are we? Ema is building the next generation AI technology to empower every employee in the enterprise to be their most creative and productive. Our proprietary tech allows enterprises to delegate most repetitive tasks to Ema, the Universal AI employee. We are founded...SuggestedFull timeWork experience placementWork at office3 days per weekEma
Remote8 hours ago$135k - $200k
...About Ema Ema is building the world’s leading Agentic AI platform to transform enterprise productivity. We enable organizations to delegate repetitive tasks to Ema, the Universal AI Employee, delivering 10x gains in workforce efficiency, across functions. Founded by former...SuggestedFull timeEma
Remote8 hours ago- ...and understanding of sample size calculation Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH) Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw...SuggestedFull timeInterim role
$80.6k - $145k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workInterim roleFlexible hours- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workFlexible hours
- ...industry. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take...SuggestedContract workRemote work
- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workImmediate startFlexible hours
- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workFlexible hours
$134.4k - $255.4k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workWork at officeImmediate startFlexible hoursShift work$95k - $175.7k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workImmediate startFlexible hours- ...teams ~ Experience in Therapeutic Areas relevant in client pipeline is desirable ~ Understanding of major regulations (US FDA, EMA and PMDA) ~ Familiarity with guidelines and standard of care is desirable ~ Cross geographical experience. Working in multi-...SuggestedRemote jobLocal area
- ...issues or protocol deviations. Provides medical coding supervision. ~ Regulatory Compliance: Ensure adherence to ICH-GCP, FDA/EMA guidelines, and institutional policies; participate in data safety monitoring boards and meetings as needed. ~ Investigator and...SuggestedFor contractorsVisa sponsorshipWork visa
$320k - $350k
...experience preparing and reviewing nonclinical sections of global regulatory submissions and engaging with health authorities (FDA, EMA) ~ Strong ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform development...SuggestedFull time- ...industry with pharmaceutical / biotech companies. eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership...SuggestedContract workWork experience placementRemote work
$153.94k - $199.21k
...outcomes. Understands drug development phases and the nature of associated clinical trials across phases. Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures. Strong communication and organizational skills...Full timeFor contractorsLocal areaFlexible hours- ...Proficiency in SAS ; familiarity with R is highly desirable. Preferred Education, Skills, and Knowledge ~ Working knowledge of FDA, EMA, and ICH statistical guidance; experience supporting regulatory submissions including NDA, BLA, or MAA preferred. Physical...Full timeWork at officeRemote work
Iovance Biotherapeutics
Remote10 days ago $47k - $95.9k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...Contract workImmediate startRemote workFlexible hours$194k - $216k
...biotechnology industry in a Statistical Programming leadership capacity. In-depth knowledge of CDISC standards. Prior FDA and EMA submissions experience. Technical expertise and knowledge of experimental design and analyses using statistical software such as...Full timeWork at officeRemote workFlexible hours3 days per week- ...all project management aspects of assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. This includes, but is not limited to, the following: # Schedule and conduct...Remote jobFull timeContract workWork at officeWork from homeWorldwide
- ...all project management aspects of assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. # Communicate project action items and key decisions through timely minutes...Remote jobFull timeContract workWork at officeImmediate startWork from homeWorldwide
$191k - $263k
...submissions (e.g. BLA/NDA, MAA) Familiarity with eCTD format and relationships between documents. Familiarity with ICH, FDA, and EMA guidelines and regulations, as well as public disclosure requirements for documents. Proven experience authoring documents and...Full timeTemporary workFor contractorsLocal area$56.4k - $95.9k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...Contract workWork at officeFlexible hours$80.6k - $175.7k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...Contract workFlexible hours$80.6k - $145k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...Contract workFlexible hours$176.1k - $287.3k
...R. ~ Proven track record of delivering analyses supporting regulatory submissions and engaging directly with agencies (e.g., FDA, EMA, PMDA). ~ Hands-on experience with a broad range of quantitative and computational tools and a strong publication record. ~ Exceptional...Remote job$120k - $140k
...with SaaS or document management solutions is required. Documented contract sales experience is required. Knowledge of FDA, EMA, ICH guidelines, or other regulatory bodies is a plus. Previous exposure to the biotech, pharmaceutical, or clinical research...Full timeContract workRemote work- ...pharmaceutical, biotech, and medical device companies operate, including their global regulatory and compliance pain points (e.g., FDA, EMA, GxP). ~10+ years of professional sales experience, with a significant portion dedicated to B2B SaaS commercial sales leadership on...Remote workWorldwide
$80.6k - $175.7k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...Contract workFlexible hours$180k - $205k
...decisions. ~ Regulatory and CMC experience , including authoring or reviewing technical documentation and familiarity with FDA, EMA, and/or other global regulatory expectations and inspections. ~ Experience managing external partners , with the ability to provide...Full timeContract workRemote work
