Kristin Sless’ Post

Real people. Real Solutions. With our staffing DNA, we know how to find the right consultants and talent for the right roles, whether that is to develop strategies, build and manage programs, or execute key projects. When implementing plans to get it done, we are there with you. To the finish line. To learn more about how we can support your needs, connect with a member of our team today! #lifesciences #quality #medicaldevice #biopharma #regulatory #consentdecree

The pharmaceutical industry is navigating a rapidly evolving landscape with several impactful challenges: 1. Rising R&D Costs & Declining Productivity Skyrocketing development costs often exceed billions of dollars. Long development timelines impact ROI. Declining success rates through clinical trials. 2. Regulatory Compliance & Changing Regulations Complying with rigorous and evolving global regulatory standards. Ensuring compliance across different countries adds complexity. 3. Intellectual Property & Patent Challenges Patent expiries lead to significant revenue losses. Stiff competition from generic manufacturers. Costly legal battles over patent rights. 4. Pricing Pressures & Market Access Increased scrutiny and pressure to lower drug prices. Challenging reimbursement processes. Complex market access barriers in different regions. 5. Technological Advances & Integration Integrating AI, machine learning, and big data is costly and complex. Growing cybersecurity risks. Significant investment required for digital transformation. 6. Supply Chain Disruptions Vulnerabilities in global supply chains. Impact of events like COVID-19 on supply chain resilience. Maintaining quality control across global suppliers. 7. Ethical & Social Responsibilities Ensuring equitable access to medications globally. Increasing demand for clinical trial transparency. Emphasis on environmental sustainability. 8. Workforce & Talent Management Shortages of skilled professionals in specialized areas. Challenges in retaining talent & hiring the right talent. Continuous training needed to keep up with advancements/compliance. 9. Market Competition & Innovation Pressure - Continuous innovation needed for new therapies. - Competitive landscape with small biotech firms driving innovation. - Frequent mergers and acquisitions leading to integration challenges. KEY - Hire the right talent to help navigate through these challenges which requires strategic planning, tech investments, regulatory foresight, and a focus on patient-centric solutions. Let's discuss how my team can partner with you to strategically solve some of your workfoce and talent management challenges so the right people can be put in place to help iron out some of the above. #pharmajobs #qualityjobs #qualityassurance #pharma 🎯EXPERIENCE MATTERS, IT TAKES ONE TO KNOW ONE!    💥Life Science Recruiting & Consulting in Canada 🍁 & USA 💥     Practice Lead in Pharma and Healthcare @ The Staffing Exchange            👉🏼 www.gxpsolutions.ca      📧 mandy@gxpsolutions.ca   ☝🏼 Like this and want more interesting content? 🔔 If you like my content, please follow me Mandy Wagner, PMP and 'hit' the bell. Share if others could benefit from this too! My #s: 👇🏼  #recruitment #lifesciences #QA #quality #qualityassurance #qualityjobs #qualityconsulting #pharmaceuticals #pharmaindustry #pharma #biotechnology #healthcare #recruitmentagency #hireright #resumetips

Why is Regulatory Compliance Important? What Does It Involve? I’m eager to shed light on the importance of compliance in industries like Pharmaceuticals, Medical Technology, Biotechnology, and healthcare software (such as EDC for clinical trials or EMR systems). Simply put, regulatory compliance ensures that companies follow the rules set by regulatory authorities like the FDA or EMA to ensure that products and services are safe and effective. Whether it’s a medical device, a new drug, or software designed to manage clinical trials, compliance ensures that everything is done ethically, with patient safety and security as the top priority. Why is this so important? -> It protects patients by ensuring safety and effectiveness. -> It enhances the credibility and trustworthiness of businesses in the industry. -> It helps companies avoid fines, penalties, and reputational damage. Ensuring that teams have the knowledge and skills to understand and navigate these regulations successfully should be the core focus of any Compliance professional in the life sciences field. If you’re curious about how compliance impacts our work or have any questions, feel free to reach out! I’m happy to chat. 😀 #RegulatoryCompliance #LifeSciences #PatientSafety

#regulatoryaffairs (RA) is a tough job by any measure, a pressure cooker of existing, new and ever-changing #pharmaceutical regulations, with tight deadlines for submissions, and wide-ranging responsibilities that, on any given day, may include updating databases, working on submission documents, reviewing #labelling and #packaging, rewriting #documentation, proofreading changes and much more. It may come as a surprise, but chance and a transfer within an organization – rather than a career choice from the outset – is how most regulatory affairs careers begin. Now-a-days the challenges for a Regulatory affairs #professional shift more and more to #strategic #planning and shaping the regulatory landscape. Pure filing, dossier compiling and publishing, submissions, team #management and hundreds of emails, all contribute to a never-ending daily grind! For more check the #workshops index link: https://lnkd.in/drtPxKcc #ra

Experience in pharmaceutical companies brings numerous important benefits which includes : 1. Deep Knowledge : Experienced employees understand industry regulations, drug development processes, and market trends. 2. Operational Efficiency : They streamline processes, saving time and resources. 3. Innovation: Their insights help in creating better products and effective marketing strategies. 4. Strong Relationships : Long-term employees build strong connections with healthcare providers, regulators, and other key players. 5. Crisis Management : They effectively handle disruptions, ensuring the company runs smoothly. 6. Mentorship:They train and guide new employees, promoting continuous improvement. 7. Strategic Planning: Experienced professionals contribute to long-term strategic planning and decision-making. 8. Customer Satisfaction: They ensure that products and services meet high standards, enhancing customer trust and satisfaction. 9. Regulatory Compliance: They navigate complex regulations efficiently, minimizing legal risks. 10.Cost Management : Their experience helps in optimizing costs without compromising quality. 11. Company Culture : Long-term employees help maintain and propagate the company's values and culture. These advantages help pharmaceutical companies thrive, innovate, and stay competitive in the market. #Pharmaceuticals #pharma #experience

Navigating a CDO interview in the Biotech field? Here's how to ace it! A Chief Development Officer leads the quest for new products and technologies, managing research, clinical trials, regulatory affairs and product commercialization. They pioneer innovation while harmonizing growth. Want to impress your future employer with comprehensive knowledge about this important role? Dive deeper into its nuances here: https://lnkd.in/dgTR-QiC #CDO #Biotech #CareerPreparation

At Intellitron Research, we specialize in providing world-class solutions across key focus areas: 🔍 Regulatory Affairs: Expert guidance in global regulatory strategies, submissions, and compliance, ensuring smooth market access and product lifecycle management. 💡 Medical Affairs: Enhancing scientific communication, KOL engagement, and strategic medical planning to maximize product impact and drive value. ✔️ QA/Compliance: Comprehensive quality assurance and compliance services, maintaining the highest standards in line with global regulatory requirements. 🌐 Digital Transformation: Innovative technology solutions that drive efficiency, data-driven decision-making, and seamless digital integration. Why Partner with Us? Our leadership team brings over 25 years of global experience in the life sciences industry, combining deep expertise with a passion for excellence. We’re dedicated to delivering tailored solutions that empower our clients to excel in a rapidly evolving healthcare landscape. Connect with us to learn how we can help you achieve your strategic goals! #LifeSciences #RegulatoryAffairs #MedicalAffairs #QualityAssurance #DigitalTransformation #Pharma #Biotech #MedicalDevices #Compliance #Innovation #Experience

🚀 Awesome position alert 🚀 Oxford Nanopore Technologies is hiring a Senior Director of Regulatory Affairs, and I can't help but feel a little envious—wishing I had regulatory experience commensurate to this role: https://lnkd.in/gwPj53fD The upcoming launch of the Q-Line sequencing portfolio (kicking off with the GridION™ Q in 2025) represents the cusp of real-time, on-demand nanopore sequencing in a clinical-grade format, and it's poised to be the backbone for routine, long-term workflows in clinical and applied settings by mid-2025. 🌐 I see tremendous potential in the third generation of genome-sequencing technologies - in particular when built on a foundation that's ISO 9001:2015 compliant and adheres to 21 CFR Part 11 & EU GMP Annex 11 standards. OK, but *why* is this so exciting? It's not just the ability to bring epigenomics and epitranscriptomics into clinical practice, or to revolutionize pharmacogenomics ... Rather, as just one example, I'll offer this: there are good reasons to suspect that adaptive sequencing can streamline (clinical) genome-slicing protocols in ways that NGS-based assays cannot ... Finally, if none of that is exciting enough, the rapid evolution of the US and European regulatory landscapes promises a stimulating environment for those capable of navigating the intersection of technological innovation and regulatory frameworks. Can't wait to see who #ONT chooses for this role to maximize clinical impact! #Genomics #CareerOpportunity #RegulatoryAffairs #QLine #ISO9001 #ClinicalSequencing

In-licensing requires very complex decision making and a key component of this process is the evaluation of in-licensing candidates. 🎥 In the below short video Dr. Carlos N. Velez, CELforPharma faculty member and life sciences BD&L expert, outlines 𝗮 𝗵𝗼𝗹𝗶𝘀𝘁𝗶𝗰 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 𝘁𝗼 𝗴𝘂𝗶𝗱𝗲 𝘁𝗵𝗲 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗶𝗻-𝗹𝗶𝗰𝗲𝗻𝘀𝗶𝗻𝗴 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀 𝗶𝗻 𝗽𝗵𝗮𝗿𝗺𝗮: 1️⃣ Strategy Alignment 2️⃣ Revenue Potential 3️⃣ Cost Considerations 4️⃣ Deal Structure 5️⃣ Risk Assessment and Mitigation 👉 While this framework paints a holistic picture of the in-licensing opportunity, it's also important to remember: ⚠️ As the landscape is not static, 𝗰𝗼𝗻𝘀𝘁𝗮𝗻𝘁 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗮𝗻𝗱 𝗿𝗲𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗼𝗳 𝘁𝗵𝗲𝘀𝗲 𝗳𝗮𝗰𝘁𝗼𝗿𝘀 𝗮𝗿𝗲 𝘃𝗶𝘁𝗮𝗹 as market dynamics, regulatory landscapes, and internal strategies evolve. ⚠️ Successful implementation of this framework 𝗱𝗲𝗺𝗮𝗻𝗱𝘀 𝗮 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗲𝗳𝗳𝗼𝗿𝘁, drawing insights from cross-functional teams encompassing R&D, commercial, regulatory, and finance. Their diverse perspectives aid in a more nuanced evaluation, ensuring informed and prudent decision-making. -------- ☝️ I am Inge 🔥 My mission: Helping Pharma managers acquire business-critical competencies to make better decisions Liked this post? Want to see more? 🔔 Ring the bell on my Profile to get notified 🔝 Connect with me  #pharma #biotech #businessdevelopment #licensing

The recent announcement from the White House regarding the enforcement of the Inflation Reduction Act (IRA) in the pharmaceutical sector marks a pivotal moment for the industry. As we step into 2024, this move could significantly reshape the job landscape in #pharma and #biotech. With the #IRA enforcing rebates for drugs whose prices surpass inflation rates, pharmaceutical companies are now under increased financial pressure. This could lead to a strategic shift in how these companies operate, potentially influencing their #hiring and investment decisions. The focus might pivot more towards cost efficiency and price regulation compliance, potentially affecting roles in pricing strategy, market access, and regulatory affairs. For biotech firms, particularly those in the early stages, the emphasis on cost-effectiveness and #affordability might drive a greater need for innovation in drug development. This could lead to an increased demand for R&D professionals who can navigate the challenging terrain of developing effective yet economically viable drugs. Moreover, the potential use of "march-in" rights by the #Biden Administration to retract patents for high-priced drugs introduces a new dynamic. This could lead to more competitive and innovative practices within the industry, possibly creating new job opportunities in intellectual property management and legal advisement. In essence, while these #regulations aim to make healthcare more affordable, they also signal a transformative period for the job market in the pharma and biotech sectors. Professionals in these industries may need to adapt to a rapidly evolving landscape, one where regulatory compliance and cost-effectiveness become paramount. As we navigate these changes, it's crucial to stay informed and agile, ready to embrace the new opportunities that these shifts might bring.