regulatory affairs analyst

Arcera Life Sciences

<div>
 
 Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.
 
 
 
 
 
 This position is based in
 
 Cairo, Egypt
 
 and will report directly to the
 
 Regulatory Affairs Lead, GULF.
 
 The role will be responsible to support the RA Lead on all regulatory activities of assigned products within the Gulf region (UAE, Bahrain, Kuwait, Oman and Qatar). Ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs as well as support the Business through strong cross-functional collaboration.
 
 
 
 
 
 
 Your Responsibilities will be:
 
 
 
 
 
 <ul>
 <li>
 Support the Regulatory Affairs Lead on all the assigned Regulatory activities within the Gulf.
 </li>
 <li>
 Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.
 </li>
 <li>
 Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).
 </li>
 <li>
 Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.
 </li>
 <li>
 Responsible of ordering and legalization of local CPP and other module 1 documents for local products.
 </li>
 <li>
 Perform regulatory due diligence on module 1 for all assigned products for the Gulf according to internal process/guidance according to EU/local Region regulatory requirements.
 </li>
 <li>
 Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.
 </li>
 <li>
 Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.
 </li>
 <li>
 Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.
 </li>
 <li>
 Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.
 </li>
 <li>
 Maintain the Regulatory databases: drug track and docubridge for local products.
 </li>
 <li>
 Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
 </li>
 <li>
 Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
 </li>
 <li>
 All trainings to be completed as per training plan.
 </li>
 </ul>
 
 
 
 
 
 Your Profile:
 
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmacy or a relevant field.
 </li>
 <li>
 0 &ndash; 3 years of experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.
 </li>
 <li>
 Fluent level in English and Arabic both in oral and written communication.
 </li>
 </ul>
 
 
 
 
 This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!
 
</div>

Regulatory Affairs Associate, GULF

Masimo

<div>Duties &amp; Responsibilities:
<ul><li>Process and maintain international filings/registrations in the assigned countries within the META Region.
</li><li>Generate and maintain product and process compliance checklists for the assigned countries.
</li><li>Maintain up-to-date knowledge on applicable regulatory requirements in the assigned countries.
</li><li>Provide counsel, training, and interpretation of applicable META Region regulatory requirements to company personnel.
</li><li>Liaise with in-country representatives on all matters relative to product and process regulatory requirements.
</li><li>Support operations, marketing, and sales with global market approvals for product shipment.
</li><li>Prepare and maintain other regulatory documentation, as needed in the assigned countries.
</li><li>Contribute to the implementation of regulatory best practices and efficient processes for regulatory information management.
</li><li>Generate/update quality system procedures owned by Regulatory Affairs, as required.
</li><li>Participate in relevant projects as regulatory subject matter expert.
</li><li>Perform other duties or special projects, as assigned.
</li><li>Collaborate with QA to drive Quality compliance in the region 
</li></ul>Minimum Qualifications:
<ul><li>Minimum 3 years of experience in international medical device Regulatory Affairs.
</li><li>Experience with the current Middle East regulations
</li><li>Excellent verbal and written communication skills in English.
</li><li>Experience working remotely with in-country representatives and with USA-based headquarters.
</li><li>Excellent prioritizing, organizational and interpersonal skills.
</li><li>Willingness to accommodate a flexible working schedule across time zones that may involve evening and weekend working hours depending on project requirements.
</li><li>Ability to work in a fast-paced environment, with multiple tasks/projects.
</li><li>A detailed-oriented individual with a &ldquo;can do&rdquo; attitude and ability to work in a team environment as well as individually with minimal supervision. 
</li></ul>Preferred Qualifications: 
<ul><li>3-7 years of related work experience.
</li><li>Experience in patient monitoring systems, hospital-based equipment, software or electronic devices.
</li><li>Good knowledge of the META Region regulations on electro-medical devices.
</li><li>Experience interacting with regulatory bodies.
</li><li>Proficient in document management systems, such as Oracle Agile PLM.
</li><li>Prior experience working within countries in Middle East &amp; Africa.
</li><li>Prior experience working in international organizations. 
</li></ul>Education: 
BA/BS Degree, or equivalent combination of education and experience is required. Preferred degrees in sciences, engineering, or biomedical engineering. 
Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?
Please send your full application.
To learn more about us, please visit: www.masimo.com</div>

Regulatory Affairs Specialist I

Wells Fargo

<div>Title: Business Analyst &ndash; Regulatory &amp; Compliance
Location: 550 S Tryon St. Harris Blvd Charlotte, NC 
Duration: 12 months 
Schedule: 3 days in office/2 day remote
Work Engagement: W2
Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits
Summary:
Seeking a highly analytical Business Analyst with strong regulatory and compliance experience to support initiatives impacting the Corporate &amp; Investment Banking (CIB) business. This role will focus on assessing regulatory changes, understanding business impact, and driving clear requirements across compliance, technology, legal, and operations. 
This is a true Business Analyst role that requires someone who can operate independently, engage stakeholders effectively, and dig deep into complex problems.
Responsibilities:<ul><li>
Analyze regulatory requirements and assess impacts across business, technology, legal, and operations teams</li><li>
Partner with stakeholders to gather, document, and refine detailed business and functional requirements</li><li>
Support regulatory-driven initiatives, ensuring alignment with compliance expectations and delivery timelines</li><li>
Work against defined SLAs and timelines to deliver high-quality analysis and documentation</li><li>
Interpret and translate complex regulatory requirements into actionable business insights</li><li>
Support regulatory reporting and data analysis efforts</li><li>
Engage with cross-functional teams within CIB and frontline business units</li><li>
Identify risks, gaps, and dependencies related to regulatory changes</li></ul> 
Qualifications:<ul><li>
Applicants must be authorized to work for ANY employer in the U.S. This position is not eligible for visa sponsorship.</li><li>
Strong background in regulatory and compliance initiatives (U.S. and/or global)</li><li>
Experience supporting regulatory reporting and data analysis</li><li>
Solid understanding of financial markets and banking operations</li><li>
Proven ability to assess regulatory impact across multiple business functions</li><li>
Excellent written and verbal communication skills</li><li>
Demonstrated ability to work independently and manage stakeholder relationships</li><li>
Strong analytical, problem-solving, and critical thinking skills</li><li>
Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint</li><li>
Experience with financial industry regulations (U.S. or global frameworks)
</li><li>Prior experience supporting Corporate &amp; Investment Banking (CIB) or frontline banking teams
</li><li>Exposure to enterprise regulatory programs or large-scale compliance initiatives</li></ul></div>

Business Analyst – Regulatory & Compliance (contract)

GoFundMe

<div>
 
 Want to help us help others? We&rsquo;re hiring!
 
 
 
 GoFundMe is the world&rsquo;s most powerful community for good, dedicated to helping people help each other. By uniting individuals and nonprofits in one place, GoFundMe makes it easy and safe for people to ask for help and support causes&mdash;for themselves and each other. Together, our community has raised more than $40 billion since 2010.
 
 
 Join us! The GoFundMe team is searching for our next Senior Regulatory Affairs Governance Analyst to help contribute to the development, implementation, and maturation of the organization&rsquo;s regulatory governance program, aligning compliance initiatives with evolving regulatory obligations, risk themes, and strategic priorities. You&rsquo;ll lead projects that shape the internal control environment, support oversight activities, and drive forward policy and governance frameworks.
 
 
 
 The Job
 
 
 
 <ul>
 <li>
 Shaping and refining compliance frameworks, operating models, and governance structures to support long-term program effectiveness Developing or supporting compliance metrics and reporting to monitor program health, identify gaps, and guide decision-making
 </li>
 <li>
 Conducting regulatory gap analyses, partnering with stakeholders to assess and document control effectiveness, and developing actionable recommendations to address areas of non-compliance or risk
 </li>
 <li>
 Leading and supporting policy and framework development by identifying regulatory requirements, coordinating reviews across stakeholders, and maintaining policy governance structures
 </li>
 <li>
 Advising cross-functional teams on regulatory expectations and internal compliance requirements during the development or enhancement of processes, systems, or products
 </li>
 <li>
 Designing and delivering compliance training to promote awareness, accountability, and understanding of regulatory obligations and internal standards
 </li>
 <li>
 Supporting the integrity of resiliency planning through coordination of documentation reviews and participation in testing
 </li>
 <li>
 Facilitating risk assessments, monitoring remediation plans, and reviewing program implementation to evaluate control design and effectiveness
 </li>
 <li>
 Preparing and delivering concise, well-structured reports and presentations to senior leadership and key stakeholders on compliance risks, trends, gaps, and remediation efforts
 </li>
 <li>
 Monitoring and synthesizing changes in the regulatory landscape, translating them into actionable insights and program updates
 </li>
 <li>
 Managing Second Line responses to regulatory inquiries, audits, and internal reviews by collaborating with business owners to compile documentation and address feedback
 </li>
 <li>
 Tracking the progress of compliance-related initiatives and providing constructive, risk-based feedback to teammates
 </li>
 <li>
 Building and maintaining collaborative relationships with internal stakeholders and external partners to promote a strong culture of compliance and proactively identify emerging risks
 </li>
 <li>
 Providing informal mentorship and support to peers by sharing knowledge, reviewing work, and contributing to team development
 
 
 </li>
 </ul>
 
 You
 
 
 
 <ul>
 <li>
 Bring 3+ years of experience in compliance, risk management, or a related governance role, ideally within a Second Line of Defense function
 </li>
 <li>
 Understand how to interpret regulatory requirements and translate them into clear, actionable guidance
 </li>
 <li>
 Communicate clearly and confidently, adapting your message for different audiences and levels of technical detail
 </li>
 <li>
 Are detail-oriented without losing sight of the bigger picture, especially when balancing regulatory expectations with operational realities
 </li>
 <li>
 Work independently, prioritize effectively, and take ownership of your deliverables
 </li>
 <li>
 Are energized by building and evolving programs, not just maintaining them
 </li>
 <li>
 Are comfortable navigating ambiguity and contributing to the development of new policies, frameworks, and documentation
 </li>
 <li>
 Build strong cross-functional relationships and influence outcomes through thoughtful collaboration
 </li>
 <li>
 Have experience supporting or working with global teams, and can adapt to different regulatory, cultural, or operational contexts
 </li>
 <li>
 Take pride in producing high-quality, strategic work that strengthens organizational compliance and enables long-term success
 
 
 </li>
 </ul>
 
 Why you&rsquo;ll love it here
 
 
 
 <ul>
 <li>
 Make an Impact: Be part of a mission-driven organization making a positive difference in millions of lives every year.
 </li>
 <li>
 Innovative Environment: Work with a diverse, passionate, and talented team in a fast-paced, forward-thinking atmosphere.
 </li>
 <li>
 Collaborative Team: Join a fun and collaborative team that works hard and celebrates success together.
 </li>
 <li>
 Competitive Benefits: Enjoy competitive pay and comprehensive healthcare benefits.
 </li>
 <li>
 Holistic Support: Enjoy financial assistance for things like hybrid work, family planning, along with generous parental leave, flexible time-off policies, and mental health and wellness resources to support your overall well-being.
 </li>
 <li>
 Growth Opportunities: Participate in learning, development, and recognition programs to help you thrive and grow.
 </li>
 <li>
 Commitment to DEI: Contribute to diversity, equity, and inclusion through ongoing initiatives and employee resource groups.
 </li>
 <li>
 Community Engagement: Make a difference through our volunteering program.
 
 
 </li>
 </ul>
 
 We live by our core values:
 
 
 impatient to be great
 
 ,
 
 find a way
 
 ,
 
 earn trust every day
 
 ,
 
 fueled by purpose
 
 . Be a part of something bigger with us!
 
 
 GoFundMe is proud to be an equal opportunity employer that actively pursues candidates of diverse backgrounds and experiences. We do not discriminate on the basis of race, color, religion, ethnicity, nationality or national origin, sex, sexual orientation, gender, gender identity or expression, pregnancy status, marital status, age, medical condition, mental or physical disability, or military or veteran status.
 
 
 The total annual salary for this full-time position is $75,000.00 - $112,000.00 + equity + benefits. As this is a remote position, the salary range was determined by role, level, and possible location across the US. Individual pay is determined by work location and additional factors including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range based on your location during the hiring process.
 
 
 If you require a reasonable accommodation to complete a job application or a job interview or to otherwise participate in the hiring process, please contact us at accommodationrequests@gofundme.com.
 
 
 
 Global Data Privacy Notice For Job Candidates And Applicants
 
 
 
 Depending on your location, the General Data Protection Regulation (GDPR) or certain US privacy laws may regulate the way we manage the data of job applicants. Our full notice outlining how data will be processed as part of the application procedure for applicable locations is available here. By submitting your application, you are agreeing to our use and processing of your data as required.
 
 
 
 Learn More About GoFundMe
 
 
 
 We&rsquo;re proud to partner with GoFundMe.org, an independent public charity, to extend the reach and impact of our generous community, while helping drive critical social change. You can learn more about GoFundMe.org&rsquo;s activities and impact in their FY &lsquo;24 annual report.
 
 
 Our annual &ldquo;Year in Help&rdquo; report reflects our community&rsquo;s impact in advancing our mission of helping people help each other.
 
 
 For recent company news and announcements, visit our Newsroom.
 
 
 
 Notice to Applicants for Jobs Located in NYC or Remote Jobs Associated With Office in NYC Only
 
 
 
 We use Metaview as part of our hiring process for jobs in NYC and certain features may qualify it as an automated employment decision tool (AEDT), as defined by New York City Local Law 144. As part of the hiring process, we provide Metaview with job requirements and candidate submitted resumes and application materials to assist in evaluating job-related qualifications. While this tool is used to improve efficiency and support our recruiting personnel, all final hiring decisions are made by GoFundMe employees.
 
 
 We began using Metaview on March 10, 2026. The Metaview tool has been reviewed by an independent auditor. Results of the audit may be viewed here. The tool evaluates your professional experience, technical skills, education, and other qualifications using information collected directly from your submitted resume and application materials; all such data is retained in accordance with GoFundMe&rsquo;s Personnel Privacy Notice and applicable legal requirements. If you would like to request an alternative selection process or a reasonable accommodation, please contact accommodationrequests@gofundme.com.
 
 
</div>

Analyst II, Compliance Program

Syneos Health

<div>Regulatory Labeling Manager &ndash; Artwork Development and Source Text Review(NA and LATAM Only)
<div>Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health
 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
</li></ul></div>Job Responsibilities
<ul><li>Open to hiring in North America and LATAM only with no sponsorship needs.
</li></ul><ul><li>Please submit CVs in English
</li></ul>Labeling Manager &ndash; Artwork Development and Source Text Review
Position Summary
The Labeling Artwork Reviewer is responsible for the review and approval of pharmaceutical labeling artwork to ensure compliance with regulatory requirements, internal standards, and market-specific guidelines. This role plays a critical part in ensuring the accuracy, clarity, and consistency of product package labeling across global markets.
Key Responsibilities
<ul><li>Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content.
</li><li>Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development.
</li><li>Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification.
</li><li>Training and oversight of additional FSP resources for artwork management
</li><li>Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities.
</li><li>Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs.
</li><li>Support the development and maintenance of country regional text lists (cRTL).
</li><li>Review of package component labeling (PCL) source text for compliance with Health Authority regulations for the respective countries.
</li><li>Participate in cross-functional meetings to support product launches, labeling updates, and change control processes.
</li><li>Support continuous improvement initiatives related to artwork review processes and labeling systems.
</li></ul>Required Knowledge/Skills
<ul><li>Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH) for printed components.
</li><li>Detail-oriented with excellent proofreading and quality control skills.
</li><li>Experience with annotation of artwork and working in artwork management systems.
</li><li>Familiarity with proofreading tools (e.g., TVT, Global Vision).
</li><li>Ability to work independently and collaboratively in a fast-paced environment.
</li><li>Strong communication and organizational skills.
</li></ul>Required Experience and Education Level
<ul><li>Bachelor&rsquo;s degree in Life Sciences, Pharmacy, Graphic Design, or a related field.
</li><li>2+ years of experience in pharmaceutical labeling, regulatory affairs, or artwork review.
</li></ul>Preferred Qualifications
<ul><li>Experience with global labeling and multilingual artwork.
</li><li>Knowledge of serialization, barcoding, and packaging regulations.
</li><li>Prior experience in a GMP-compliant environment.
</li></ul>At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for 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&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Regulatory Labeling Manager – Artwork Development and Source Text Review(NA and LATAM Only)

Laborers International Union of North America

Department: Corporate Affairs Salary Level: $100,000.00 &ndash; $150,000.00 Location: Washington, DCTo Apply: R&eacute;sum&eacute;s should be provided to kmatthews@liuna.org by close-of-business on May 18, 2026.SUMMARY: The LIUNA Corporate Affairs Department was created in 2004 to expand LIUNA's capacity to map, organize, activate and protect our union's assets and benefit funds. The Department helps provide resources and training for LIUNA and LIUNA fund staff to enable them to meet their bargaining and fiduciary obligations. Our union recognized the growing need to provide information regarding the structure, governance, and strategic plans of corporations and industries of particular importance to our members. The Department continues to evolve so that it can better serve the needs of our members and the Locals, District Councils and Regions.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.<ul><li>Conduct quantitative and qualitative research, including financial analysis, statistical analysis, corporate, industry, and economic issue research.</li><li>Prepare corporate profiles and identify issues for investor initiatives.</li><li>Track, research and monitor corporate transactions, legal and regulatory compliance.</li><li>Provide research and analysis of private equity, infrastructure and real estate managers, limited partners, and investments.</li><li>Plan, research, write and edit quality research products including reports, presentations, issue briefs, fact sheets, talking points, letters, speeches, websites, articles, blogs and other educational and advocacy materials.</li><li>Help to promote public employee and Taft-Hartley plan best practices related service provider accountability and related issues.</li><li>Convene and manage workgroups and task forces comprised of institutional investors, affiliated union senior staff, plan trustees, and other parties.</li><li>Represent the LIUNA Corporate Affairs Department in a variety of forums, including at shareholder meetings and conferences, on webinars and conference calls, with investor coalitions and the media.</li><li>Engage corporate executives, directors and managers on behalf of LIUNA, affiliated locals, regions and district councils or pension plans as needed.</li></ul>SCOPE &amp; NATURE OF SUPERVISION: The Investment Analyst is responsible for developing and implementing department programs, issue areas, campaigns and initiatives. Under the direction of the department Director, the Investment Analyst serves as a project lead and supports the work of the LIUNA Corporate Affairs Department.REQUIREMENTS AND QUALIFICATIONS:<ul><li>Commitment to the mission and values of LIUNA.</li><li>Experience conducting advanced corporate research and financial analysis to support campaign initiatives.</li><li>Experience with union organizing campaigns.</li><li>Experience with corporate compliance filings.</li><li>Academic or professional background in labor, economics, finance, investments, construction.</li><li>Excellent written and oral communication skills, including the ability to produce clear and timely analysis of business and economic issues and events.</li><li>Strong interpersonal skills, including experience convening, leading and managing multi-stakeholder groups.</li><li>Proficiency in Internet-based research, word processing, spreadsheet programs, statistical analysis.</li><li>Experience with public speaking.</li><li>Ability to work both independently and collaboratively to meet deadlines, and multi-task in a fast paced campaign environment.</li><li>Flexibility to travel in performance of duties.</li><li>Ability to work extended or irregular hours as needed.</li></ul>Pay: $100,000.00 - $150,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Health insurance</li><li>Retirement plan</li></ul>Work Location: In person

Investment Analyst

SPECTRAFORCE

<div>
 
 
 Position Title:
 
 Analyst, Data Analytics
 
 
 
 Work Location:
 
 Irvine, CA (Hybrid)
 
 
 
 Assignment Duration:
 
 12 Months
 
 
 
 
 
 
 Position Summary:
 
 
 
 Perform quantitative analysis using Python (e.g., pandas, NumPy, visualization libraries) to support clinical trial operations such as enrollment, costing, and resourcing, and to develop forecasting and decision-support outputs for key stakeholders (e.g., Clinical Affairs, Regulatory and Medical Affairs, Strategy, Global Supply Chain, Finance).
 
 
 Investigate, assess, and interpret clinical and operational data to support strategic decision-making, including early signal detection related to enrollment trends, protocol adherence, site performance, and data quality, while proposing moderately complex solutions and recommendations.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 
 &bull; Perform quantitative analysis using Python (e.g., pandas, NumPy, visualization libraries) to support clinical trial operations such as enrollment, costing, and resourcing, and to develop forecasting and decision-support outputs for key stakeholders (e.g., Clinical Affairs, Regulatory and Medical Affairs, Strategy, Global Supply Chain, Finance).
 
 
 &bull; Investigate, assess, and interpret clinical and operational data to support strategic decision-making, including early signal detection related to enrollment trends, protocol adherence, site performance, and data quality, while proposing moderately complex solutions and recommendations.
 
 
 &bull; Modify, extend, and maintain analysis tools and workflows&mdash;primarily in Python&mdash;by leveraging existing clinical models (e.g., inventory, case management, headcount, trial enrollment, site activations/deactivations) while applying clinical trial domain knowledge.
 
 
 &bull; Organize, analyze, and create reproducible analyses, reports, dashboards, and data extracts to summarize moderately complex challenges across clinical affairs projects, programs, and initiatives.
 
 
 &bull; Apply statistical methods (e.g., descriptive statistics, trend analysis, basic inferential methods) as appropriate to quantify uncertainty, monitor performance, and support interpretation of clinical and operational signals.
 
 
 &bull; Lead portions of clinical analytics projects in collaboration with cross-functional stakeholders (e.g., Clinical Operations, Biostatistics, vendors, and internal analytics partners).
 
 
 &bull; Identify and propose data-driven process improvements related to clinical affairs operations (e.g., screening efficiency, site start-up, physician training, data review workflows).
 
 
 &bull; Other duties as assigned.
 
 
 
 
 
 
 Qualification &amp; Experience:
 
 
 
 &bull; Bachelor's Degree Required
 
 
 &bull; 3 years of previous related experience Required
 
 
 &bull; Experience in a quantitative, analytical, or programming-heavy role Preferred
 
 
 &bull; Experience working in clinical research or clinical trial operations within the medical device industry Preferred
 
 
 &bull; Strong proficiency in Python for data analysis, including developing maintainable scripts and notebooks for clinical and operational datasets
 
 
 &bull; Proven expertise in Excel and PowerPoint and other MS Office Suite applications (Word, Access)
 
 
 &bull; Solid understanding of quantitative and statistical methodologies, with the ability to apply them pragmatically in a clinical operations context
 
 
 &bull; Experience with signal detection, trend monitoring, or anomaly identification in complex datasets preferred
 
 
 &bull; Good written and verbal communication skills and interpersonal relationship skills
 
 
 &bull; Strong problem-solving, organizational, analytical, and critical-thinking skills
 
 
 &bull; Moderate knowledge and understanding of client's policies, procedures, and guidelines relevant to clinical trial data analytics
 
 
 &bull; Strict attention to detail and data quality
 
 
 &bull; Ability to interact professionally with all organizational levels
 
 
 &bull; Ability to manage competing priorities in a fast-paced environment
 
 
 &bull; Ability to work collaboratively in team and cross-functional environments
 
 
 &bull; Ability to build productive internal and external working relationships
 
 
 &bull; Adhere to all company rules and requirements (e.g., Environmental Health &amp; Safety policies) and take appropriate measures to protect people, data, and the environment.
 
</div>

Analyst, Data Analytics

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