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Real World Data Scientist (home office)
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Associate Director / Director Medical Affairs Sub-Region Europe
BeiGene Switzerland GmbH, Basel
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The (Associate) Medical Director Haematology, Sub-Region Europe (SRE) is the internal key expert within the indication area(s), directly supporting the respective products in the sub-region through development, pre-marketing, launch, marketing support and lifecycle management. This includes all areas of medical affairs activities such as support of safe and appropriate product use, data-generation, data dissemination and regional educational activities. Subject matter expertise is essential. The role is part of a matrix organization, reporting to the Senior Medical Director of SRE, but with strong collaboration with the SRE Medical Affairs teams, Global Medical Affairs functions, Global Clinical Operations and Development Functions as well as regional Commercial and Market Access Colleagues. It requires close interaction with SRE Country Medical Directors and their respective teams to assure strategic dialogue considering local specifics and input as well as global company guidance with respect to allocated disease areas. SRE currently includes Switzerland, The Netherlands, Poland, the Nordic countries and Central, Eastern Europe & Greece (CEEG). Essential Functions of the Job: As a subject matter expert for the assigned disease area, the incumbent will be accountable to develop regional strategies and activities to support the overarching objectives in the given disease areas. 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Develop initiatives to upskill Field Medical associates, to ensure continued learning and scientific excellence. Work closely with Clinical Operations and Clinical Development to ensure Clinical Trial deliverables whilst also working closely with Market Access and Commercial to shape the future go to market strategy for Pipeline Products In addition to generation of scientific data to support medical claims, provide input for the generation of health economic outcome data to support reimbursement. Work with medical staff to support integration and communication to regulatory and development teams with strategic medical input where appropriate; ensure regional medical affairs activities are scientifically sound, within relevant guidelines, and of a high standard. Provide input and guidance to medical information and strategy team within the Region to support optimal medical communications and development strategies for the Region. Recommend new Regional studies, medical affairs activities and investments to Global Medical Affairs leadership. Ensure compliance with Regional directives for, amongst others, the release of promotional material, medical representative training materials, and medical information. Together with other members of the Global Medical Affairs team, establish and maintain strong relationships with key opinion leaders for and on behalf of BeiGene in all relevant areas to promote the Company’s reputation, dedication to patients, and expertise in these areas. Lead and participate in Regional Medical and Scientific forums (i.e., advisory boards and educational) that involve scientific leaders. Supervisory Responsibilities: The role will not have any direct reports. Experience/Qualifications: MD, with relevant Clinical/Scientific and Industry experience in Haematology, preferably in CLL and Lymphoma. Minimum 10 years of experience and success within other biotech/pharmaceutical companies. 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Experience delivering effective and persuasive communications on complex and controversial topics to both corporate management and scientific audiences. High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills. Highest ethical standards in corporate medical governance. Flexibility to work with colleagues in a regional setting. Able to engage in work-related travel approximately 30% Excellent written and oral communication skills. English proficiency mandatory. Travel: Ability to Travel Reports To: Senior Medical Director, Sub-Region Europe Education Required: M.D. Physician with relevant clinical/scientific experience in Haematology as well as industry experience having demonstrated advanced professional knowledge and skills associated with Medical Affairs conduct as well as Clinical Development in the given therapeutic area. 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Discovery area leader in Ophthalmology subspecialty
F. Hoffmann-La Roche AG, Basel, Basel-City, Switzerland
Discovery area leader in Ophthalmology subspecialtyThe Position In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. This position sits within the Ophthalmology team which is continuously growing and innovating. We partner and collaborate with leading scientific institutions worldwide. We tackle grand challenges by assembling, funding, and leading interdisciplinary teams of experts to work on highly ambitious and complex scientific questions. Located in Basel, we focus on therapeutic approaches for eye diseases such as age related macular degeneration, diabetic retinopathy, glaucoma, dry eye, or genomics medicine. To respond to our ongoing growth, we are hiring a Discovery area leader in Ophthalmology subspecialty. We are seeking a highly motivated and experienced scientist to develop novel drugs for ocular diseases. Turning science to medicine is the goal we are looking for and as an expert in the field, you are acting as a catalyst by connecting with other groups, providing a high level of recommendations, thinking outside the box and ensuring that the projects can be delivered. Your impact and main responsibilities You are responsible for your specific field and your projects of drug development from initial ideas to the clinical trials . You define your strategy in alignment with the Head of the group and ensure the delivery of your projects (budget management, allocation of resources...) You lead the scientists and associates allocated to your projects.. Your leadership style is participative and your professionalism inspires the team. In the lab, you plan, organize, and analyze your experiments As an ambassador of pRED Ophthalmology, you communicate results about our science in peer-reviewed journals, or at scientific meetings, and collaborate with external academic and corporate partners. Who you are: Essentials You completed a PhD in sciences and bring a solid research experience with a minimum of 8 yrs after a PhD, in ophthalmology or related fields You can demonstrate a strong publication record with articles in high-impact journals (please provide a publication list with IF) showed your capability to lead independent research and a team You are recognized as a key opinion leader in the field and have proven your support in external funding (please provide a list of funding in the last 5 yrs) Desirables An experience in drug development is a clear asset for the role You reached the level of Associate or Associate Professor Your English level is fluent and you can easily lead presentation in front of a board committee You’re someone who wants to influence your own development by joining a company where you have the opportunity to pursue your interests across functions and continuously learn and innovate. You like thinking outside the box, and work with passion. You bring new ideas and also previous knowledge of your research in ophthalmology. In the ophthalmology group you have the opportunity to contribute to new innovative drugs that will make a difference in patients. Our commitment Roche commits to recognizing talent and aptitude. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career. We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more. Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events. We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer.
PhD internship in the Neuroscience and Rare Diseases Discovery and Translational Area for 12 months (m/f/d) - RiSE
F. Hoffmann-La Roche AG, Basel, Basel-City, Switzerland
PhD internship in the Neuroscience and Rare Diseases Discovery and Translational Area for 12 months (m/f/d) - RiSEThe Position PhD Internship / RiSE - Investigating the lysosomal functionality via modulating lysosomal ion channel activity as novel treatments for neurodegenerative disorders (12 months) Who we are At Roche, 98.000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we`ve become one of the world`s leading research focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other`s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves. At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. The Position The RiSE program (Roche Internships for Scientific Exchange) is a highly competitive student research program at Roche. It offers the most talented postgraduate PhD and medical degree students the opportunity to be fully integrated into our interdisciplinary and international industry R&D environment. As a RiSE student you will enhance your competencies, gain valuable work experience with us, and eventually become part of a world-wide network of RiSE Alumni. The Neuroscience and Rare Diseases Discovery and Translational Area (NRD DTA) is developing medicines for a range of serious neurological diseases, including multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, autism, spinal muscular atrophy, and Huntington’s disease. As RiSE student in the NRD DTA you will join our group in the Neurotechnology Section and perform at the Roche Innovation Center Basel, Switzerland, focusing on the establishment of lysosomal functional assays to investigate the mechanism of actions through lysosomal ion channel modulation in neurodegenerative disease models. You will be hosted and mentored by a Roche scientist who will guide you through your research and provide you with the needed work infrastructure and collaborative network. During the internship your tasks will include: Phenotypic and functional characterization of iPSC-derived neuronal and glial cells and understanding the effect of pharmacological modifications on lysosomal function via lysosomal ion channel modulation. Design, preparation, and execution of experiments and data interpretation. Present your progress and data at internal meetings. High commitment to work with a proactive mindset and in close collaboration with the team and project members in order to effectively advance exploratory projects. Who You Are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. Moreover you are/have: Enrolled in a PhD or medical degree program at a university and are looking to expand your experience with an industry internship Solid understanding of cell / molecular biology including lysosomal function and neurodegenerative disorders. Experience in pluripotent stem cell cultivation, in vitro differentiation towards neurons and glia, as well as cellular and molecular characterization thereof. Expert user of imaging tools such as confocal or high-content imaging with image analysis. Highly motivated individual eager to learn and establish cutting-edge techniques. Self-motivated and independent thinker with excellent communication skills, attention to detail, and the desire to work in a fast-paced, cutting-edge environment. Information about application documents and start date: The preferred start date of the internship is March 2024 or upon availability. Applications need to include a CV and a cover letter, as well as a letter from your academic supervisor supporting your application to the RiSE Program. Please note that due to regulations non-EU/EFTA citizens have to provide a certificate from the university stating that an industry internship is mandatory as part of the university training. Do you know what Roche stands for? Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. If you still have questions, then please check our FAQs and videos on careers.roche.ch/faq #RiSE Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. 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Medical Director - Translational Medicine (Neuroscience)
Novartis AG, Basel, Switzerland
Medical Director - Translational Medicine (Neuroscience)Job ID 384547BR Mar 05, 2024 Switzerland About the Role 2 Billion plus people are affected by diseases of the nervous system having a dramatic impact on patients and families around the world. Neurologic and psychiatric diseases remain as some of the largest challenges in medicine. Novartis is committed to changing the landscape by developing transformative treatments for important neuroscience disorders. As part of the Neuroscience (NS) departments at Novartis, you will help to develop therapies for patients with neuroimmunological disorders including multiple sclerosis. You will provide medical and scientific leadership and expertise in a role that significantly affects the entire Novartis NS pipeline. You will drive the success of both early and late stage global programs. You will provide scientific expert assessments and support for in-licensing opportunities, including due diligences. Your responsibilities will include:1. Translational Medicine (early clinical projects):• Develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in a single or multiple indications.• Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures.• Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study• Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)• Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches 2. Translational Medicine (late-stage clinical projects):In collaboration with the respective Translational Medicine Therapeutic Area Head:• Responsible for implementing studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies.• Communicate clinical team matters to Global Project Teams, relevant BioMedical Research and Development boards, and other Novartis Boards as required.• Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders• The work environment is in a matrix structure with cross-functional members from Translational Medicine, Biomedical Research and Development. Impact of this role?• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions• As a recognized specialist in Neuroimmunology, you drive the project team clinical strategy. Works globally across various Novartis divisions as well as country organizations as appropriate Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements What you will bring to the role:• Medical Degree and advanced training in neuroimmunology• An expertise in translational or laboratory research. PhD preferred but not required• Record of drug submissions / approval and / or high quality publications in international scientific journals.• Previous relevant & significant clinical study experience: either from pharma/biotech leading early phase clinical trials; a senior role within a CRO responsible for managing the medical relationship with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience.• Business fluent in English (written and spoken) Why Novartis?766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Division Biomedical Research Business Unit Translational Medicine Location Switzerland Site Basel Company / Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Apply to JobAccess Job Account
Medical Director / Rheumatology, Autoimmune Translational Medicine
Novartis AG, Basel, Switzerland
Medical Director / Rheumatology, Autoimmune Translational MedicineJob ID 385923BR Nov 01, 2023 Switzerland About the Role 30 million! That is the estimated number of patients worldwide suffering from inflammatory arthritis. Join Novartis to help find the right drugs that transform and improve patients' lives all around the world. You will join an international team of clinicians and scientists making significant impact on autoimmune diseases with high unmet medical need, taking new medicines into early-stage clinical trials: in many cases you will be the first to witness the effectiveness of a new medicine that may transform the lives of millions. Your medical and scientific leadership / expertise will significantly impacts the Novartis autoimmune drug development pipeline. Go to https://www.novartis.com/our-science and scroll to the Autoimmunity research area and Translational Medicine area for more information Your responsibilities will include:• Medical / scientific contributor and leader of complex global cross-functional teams. Our successful drug discovery and development environment has close collaboration across Research, Clinical Research and Development.• Major initiator of the Proof-of-Concept strategy and the early Clinical Development Plan. Develop and implement strategies for efficient, high value management of drug development projects leading to clinical Proof-of-Concept and competitiveness of compounds• Develop and implement disease area and biomarker strategies: contribute effectively to the preclinical and clinical Disease Area strategies, project-specific Biomarker strategy, innovative target identification and in-licensing efforts resulting in a high quality preclinical and clinical portfolio• Ensure full implementation of studies during the Proof-of-Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team, and direct or supervisory medical support for all pharmacokinetic studies• Translational Medicine representative to Health Authorities in matters and meetings that focus on early exploratory development: negotiate effectively with Health Authority representatives on all aspects of Translational Medicine and obtain results favorable to Novartis. Translational Medicine representative to Translational Medicine/medically related experts and organizations, advancing the interests of Novartis by your knowledge, style and personal skill and enhancing the position of Novartis with these individuals and groups• Contribute senior expertise to Research in support of target identification, selection, target validation and preclinical development of compounds. Review and evaluates cross-Disease Area activities at and beyond the early compound optimization stage. Provide clinical context and help design optimal preclinical studies• Evaluate clinical centers and foster communication with crucial collaborating investigators. Interact effectively with external medical and non-medical leaders and be an internal Novartis expert leader in your scientific and clinical subspecialty field. Matrix people responsibility per project: 5-8 cross-functional members from Translational Medicine plus other line functions per project team Impact of this role?• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions• As a recognized expert in your field, you drive project team clinical strategies and bring global credibility across various Novartis Institutes and Divisions as well as country organizations Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements This position is written for Director - we can hire Associate Director for those with careers that include less established science / clinical study experience. We support International family relocation and integration support to Switzerland. What you’ll bring to the role:• MD and Board certified Rheumatologist (or similar relevant sub-specialty clinical training with directly relevant patient experience) with PhD-level basic science. A completed relevant postdoctoral fellowship is strongly preferred• Advanced / business-level / fluent English (oral and written)• Recognized for your medical expertise: an experienced Clinician treating relevant patient groups at an academic medical center or private medical practice group• Recognized for your scientific expertise: respected by colleagues internally and externally, you’ve made significant contributions to your field and created / established new concepts; you have a record of high quality publications in international scientific journals• Experience designing and conducting early phase clinical trials including for inflammatory arthritis: either from pharma/biotech, a senior CRO role where you were responsible for the medical relationship and studies with Sponsors, or from a relevant academic medical center with co-PI ideally also PI clinical trial experience. 5+ years trial experience particularly in inflammatory arthritis preferred• You are used to working independently and within teams including autoimmune disease research scientists and non-scientists on study planning and execution, demonstrating competence in a broad range of project and more strategic planning skills and leading complex cross-functional/matrix project teams Your behavioural characteristics• Demonstrated passion for treating patients and science• Strategic thinker: you have created major innovations, networked with and influenced external medical leaders with your clear and logical presentation of complex strategic issues• Results-driven self-starter and decision taker• Strong cooperative team player, flexible in a changing environment• Good planning, prioritisation, problem solving and organisational skills• Resilient, energetic and enthusiastic; responding constructively to challenging new ideas and input ABOUT TRANSLATIONAL MEDICINE:Translational Medicine is a global group of scientists and physicians working at the pre-clinical and early clinical stage of drug discovery. Our Physician-Scientists drive innovative and cutting-edge science through the selection, profiling and effective global development of successful medicines, integrating clinical science into the discovery and preclinical development phase. Our Translational Medicine concepts are driven by medical needs of patients and the concept of personalized medicine, tailoring the drug, dose and dosing regimen to the patient so the clinical response is optimal in efficacy and safety. We focus from identification of drug targets (molecular pathways relevant to disease) up to the completion of Proof of Concept (Phase IIa studies). Our Translational Medicine Experts are part of preclinical project teams in all drug discovery phases and help design the pathway for First in Human studies (healthy volunteer) that bridge to studies in the patient population. They have the comprehensive responsibility for designing and executing the early clinical drug development phase with a project team including research, biomarkers, biostatistics, modeling & simulation, toxicology, technical experts and clinical trial teams. Why Novartis?766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Division Biomedical Research Business Unit Translational Medicine Location Switzerland Site Basel Company / Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Apply to JobAccess Job Account
Director Regulatory Affairs Women's Health
Abbott AG, Basel, Switzerland
Director Regulatory Affairs Women's Health Abbott Established Pharmaceuticals Division (EPD) is looking for a: Director Regulatory Affairs Women's Health for our global EPD Headquarter based in Allschwil/Basel, Switzerland. In this challenging Role you: Provide Strategic leadership for EPD Global Regulatory teams, Innovation & Developmennt (I&D) and wider EPD business in developing and executing Regulatory strategies aligned to the business plans of EPD across different products, therapies and geographies Lead cross functional team consisting members of I&D, Marketing/Commercial, Manufacturing, Finance and Licencing & Acquisition to proactively develop future strategies, KPIs, improve innovation speed to market. Provide Strategic Regulatory guidance, leadership and expertise to Regional Heads of Regulatory across all emerging markets (LATAM, India, EM - APAC, MEP, Africa, Russia & CIS) and collaborate with global (and regional) commercial to ensure alignment of RA strategies to business. Provide optimized regulatory strategies in compliance with national and international standards, deliver quality and timely support for submissions / approvals, foster interactive and positive relationship with regulatory agencies / Key opinion leaders and provide regulatory strategies to ensure maximum product potential. Core Job Responsibilities: Combined knowledge of scientific, regulatory and business issues to develop products to meet required global, regional and local regulatory requirements. Develop a comprehensive regulatory external engagements stakeholder management strategy with leadership of Regional RA and other key stakeholders of each of the business units of EPD in emerging markets Coordinate and execute strategies related to regulatory intelligence and policy, advocating Abbot’s position with Regulatory Agencies and related policy influencer groups. In collaboration with Development build advocacy positions with scientific / academic institutions and / or Regulatory Agencies to promote Abbott science with key opinion leaders. Serve on expert committees or associations to represent Abbott views externally, as required. Lead a Team of up to 7 Direct Reports Education: Bachelor Degree in related scientific discipline or Advanced degree (MS including MS RA , MEng, Ph.D) in scientific discipline preferred Experience: Demonstrated success in leading/executing Regulatory across Emerging markets Strong understanding / expertise of local / regional and Global regulatory requirements / pathways and delivery Ability to lead and drive cross functional and cross regional collaboration 5+/- years of experience at Leadership level having strong presence in Emerging markets 10+ years of experience in RA, QA, Clinical/Medical Affairs and/or Manufacturing Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf. (If you want to upload several documents, don`t save in between uploading them to be able to do so. Once you save your uploads, you will not be able to add more documents)
Director, Patient Advocacy and Policy, Europe
BeiGene Switzerland GmbH, Basel
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Director of Patient Advocacy and Policy, Europe, will develop and implement the patient advocacy and government affairs plan for BeiGene Europe, in alignment with the company’s purpose, mission, and priorities in the advancement of cancer care. The Director of Patient Advocacy and Policy, Europe leads how BeiGene engages with patients and patient organizations across our brand teams and our above brand activities. The role acts as a central subject matter expert, the owner of BeiGene’s patient-first strategy and a central point of contact for all patient engagement activities that are not clinical trial related. The successful candidate will be able to create insight-driven strategic plans in collaboration with cross-functional peers, and by partnering closely with global and regional corporate affairs as well as with the Medical Affairs Early Patient Engagement Team. This role is part of the Corporate Affairs team, reporting directly to the Head of Communications and External Affairs, Europe. The position is ideally based in Switzerland and would require traveling on a project basis. Essential Functions of the Job and Scope of responsibilities: Patient Advocacy Develop and implement an annual strategic advocacy and policy plan in alignment with the company’s priorities. Build and manage relationships with European advocacy organizations and patient groups as well as public health policy makers in key therapeutic areas (hematology/oncology) to fulfil mutual goals. Responsible for the design, coordination and implementation of patient community activities Identify and package campaignable information on disease and patient experience. Contribute to the development of BeiGene’s patient support materials led by medical and commercial to impact the patient journey. Drive the gathering of patient insights and perspectives that can inform internal and external communication campaigns and activities. Plan and lead patient organization engagement, including activities at major congresses in collaboration with the Medical Affairs Early Patient Engagement Team. Represent BeiGene at advocacy organizations, patient groups, policy events and scientific meetings as well as proactive outreach to organizations with shared priorities and values. Ensure the patient voice is heard internally supporting BeiGene’s patient-first culture. Partner with the BeiGene Europe Corporate Affairs team to make sure strategies and plans are integrated across Corporate Affairs disciplines, Communications, Patient Advocacy, and Government Affairs. Key contributor with stakeholders across relevant partners – Corporate Affairs, Commercial, Medical Affairs, Market Access and others. Policy Identify BeiGene’s priorities and objectives in terms of policy at the EU level; formalize and share with senior leaders. Identify and collaborate with Patient organizations at EU level (incl. in Brussels) to build common advocacy platforms in line with BeiGene’s patient policy priorities. Monitor, assess, and contribute to shape external European policy on key policy topics to address risks and opportunities. Provide political analysis of trends in relevant areas and impact on BeiGene, and advise senior leaders on policy and regional issues. Prepare regular updates on the Company’s EU patient and policy efforts for presentation to senior leaders. Qualifications: Bachelor’s degree. Biopharmaceutical industry and/or healthcare industry experience required (understanding of Hematology/Oncology space a plus) \"At least 10 years of patient advocacy /policy experience in healthcare, with at least three years in a corporate (pharma or biotech) setting. Deep experience in patient engagement campaign development, including integrated communications strategies to support disease awareness and patient access to innovation. Ability to build and maintain close, collaborative relationships with external stakeholders, including, but not limited to: patient advocacy organizations, trade associations, and policymakers. Ability to work cross-functionally across teams to build consensus around key priorities. ability to lead cross-function patient advocacy and policy-related work streams. Knowledge of regulatory, access, and reimbursement policies in the European setting, at European Union (EU) level, but also including non-EU and former member states. Understanding of the European Parliament, including and not limited to key issues including intellectual property, labor, taxes, and trade and other issues specific to Hematology/Oncology Skills and Abilities: Excellent English writing skills Proven relationship development and management skills. Strong cross-functional matrix management and leadership skills to foster a culture of collaboration. Works well in a fast-paced environment. Strong oral communication skills and ability to convey complex issues to a variety of audiences. Detail-oriented, with a strong ability to organize and analyze. Ability to work independently and use sound judgment in decision-making, including setting and managing priorities and meeting competing deadlines. Possesses sound judgment, critical thinking, and decision-making skills. Influences with and without authority; can effectively make a case for and follow through on strategic and tactical recommendations. High ethical standards and an appreciation of compliance requirements. Collaborative, self-directed team player. #LI-Remote BeiGene Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see www.beigene.com. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Bold Ingenuity Collaborative Spirit Driving ExcellenceÜber das Unternehmen:BeiGene Switzerland GmbH
Principal Medical Writer
Sobi, Basel
Company DescriptionSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Job DescriptionWe are looking for an experienced Medical Writer. The role is a permanent position reporting to the Head of Medical Writing. The Principal Medical Writer will provide expert leadership, strategic thinking and communication skills and expertise in the preparation of clinical regulatory documents throughout drug development, post-marketing and life-cycle management.Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise and complete scientific content aligned with the objective of the regulatory documentAssume primary responsibility for preparation of key clinical regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authoritiesProvide leadership and project coordination to cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documentsLiaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing informationAssume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development programEnsure high technical quality of the documents in compliance with in-house technical requirementsCoach and develop less experienced Medical WritersOversee and coordinate all Medical Writers assisting on documents under your responsibility, including in-house consultants and Medical Writers at CROQualificationsLife Science Master´s degree or PhDA minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processesExperience in leading complex global regulatory and clinical writing projects, such as complex CTDs, ODDs, PIPs, briefing documents and regulatory responsesExperience as lead author for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers assisting on documents under your responsibilityClear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed productsAdvanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements)Additional Information  Über das Unternehmen:Sobi
Research Histopathology Platform Head
F. Hoffmann-La Roche AG, Basel, Basel-City, Switzerland
Research Histopathology Platform HeadThe Position In Roche’s Pharmaceutical Research and Early Development organization (pRED ), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. 360 Labs Initiative at a Glance The 360 Labs are a new capability that is currently being built up within the Pharmaceutical Research and Early Development organization (pRED ). The primary mission of this effort is to provide greater access and support for the use of cutting-edge biomedical research technologies by scientists across our discovery portfolio. Operating as an integrated ecosystem, the 360 Lab environment will deliver core scientific technologies, expertise and enabling activities, as well as facilitate knowledge sharing and learning experiences in close collaboration with our therapeutic areas and functions. Together, these efforts will serve to increase the speed, enhance the robustness and improve the sustainability of our exploratory research and early discovery activities. We are currently recruiting scientific professionals with varied backgrounds in Flow Cytometry, Genomics, Proteomics, Histopathology and Microscopy / Imaging. In these new roles, your collaborative mindset is as valued as your scientific expertise. The 360 Labs are by nature a hands-on, interactive workplace where face to face presence in our labs is a priority. Our ambition is to bring to life a thriving workplace environment, acting as an highly integrated ecosystem, supporting research and development, working collaboratively, and focused on fostering excellence and sustainability. Job Mission and Impact We are offering an outstanding opportunity for a highly motivated, engaged and dynamic leader to shape the strategy of a new Research Histopathology Core Technology Platform. You will have a proven track record of engaging with senior leaders and key stakeholders and have a strong background in the histological preparation and pathological interpretation of mammalian tissues and will be a pathologist (either DVM or MD with board certification ECVP/ACVP or ABPath). You will drive the early build up and growth of the Research Histopathology Core Technology Platform and its support of discovery science within the pRED organization. Your Role and Responsibilities Act as a strategic visionary, providing key guidance and oversight in the deployment and application of histopathology approaches across the discovery research space in pRED. Serve as a key member of the 360 Labs leadership team, working closely with the Global Head, to develop a bold vision and strategy to operationalize a cutting-edge histopathology core technology platform by close interaction with senior leaders and key stakeholders. Evolve and lead a matrix team with purpose, collaborating closely with our therapeutic areas and functions to prioritize and implement sensitive and cutting-edge histopathology techniques as well as coordinate, validate and direct complex research and technology development projects to explore disease-relevant hypotheses. Drive the continued evolution of the Research Histopathology Platform by innovating new approaches, staying up to date with the scientific literature, actively engaging with internal and external histopathology communities, and continuously evaluating new technologies in the field. Your Profile Required Proven track record of engagement with senior leaders and key stakeholders and leading cross-functional teams. A pathologist (either DVM or MD) with board certification (ECVP/ACVP or ABPath) with 10 yrs professional experience in an academic setting and / or pharmaceutical industry / biotech sector, with proven effective leadership of a histopathology-focused group. An experienced experimentalist with both an in-depth theoretical and hands-on knowledge of a broad-range of histopathology approaches and novel models of animal and human disease along with their application in translational medicine. Established track record of scientific accomplishments and successful collaborations documented via publications in high-impact scientific journals and presentations at international conferences. Expert knowledge in the etiology and pathogenesis of animal disease mechanisms and processes, organ system pathology and diagnostic pathology. Awareness of, and the ability to implement novel cutting-edge approaches such as next-generation technologies in the spatial biology field. In addition to your scientific expertise and critical technical skills we are looking for candidates who: are a strategic leader that can architect a compelling vision; serve as a coach to develop and mentor junior and senior team members; and act as a catalyst by leading by example; are curious, have a growth mindset, are resourceful and flexible in problem solving, have excellent organizational skills, can think outside the box, and have a demonstrated ability to implement new ideas in a fast-paced research environment; bring excellent written communication and presentations skills with a high fluency in English; have a keen interest in continuously building a personal network and who will thrive in a dynamic, inclusive environment which gives you full accountability for your own contributions and development; have an excellent understanding of the operations processes involved in early drug discovery & development. Your Location This position is based in Basel. Our commitment Roche commits to recognizing talent and aptitude. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career. We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more. Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events. We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer.