myTomorrows

๐Ÿ‘ฅ 101-250๐Ÿ’ฐ $10,585,001 about 8 years agoPharmaceuticalClinical TrialsMedicalHealth Care๐Ÿ’ผ Private Company
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myTomorrows is a global health tech company breaking down barriers to treatment access. We connect patients with unmet medical needs and their physicians to innovative treatment options worldwide. Our primary service is facilitating access to medicines in development through our cutting-edge AI-powered technology platform. We're making a significant impact in the pharmaceutical industry by working directly with BioPharma companies, healthcare professionals, and patient advocacy groups. Our focus on Expanded Access Programs (EAPs) is central to helping patients gain access to potentially life-saving treatments. We are recognized for our remote work model, offering opportunities for flexible work arrangements, and have a global presence spanning 125 countries. myTomorrows utilizes technologies such as iPhone/Mobile Compatible, Viewport Meta, SPF, Apple Mobile Web Clips Icon, Google Tag Manager, SSL by Default, Google Font API, HSTS, DNSSEC, and Google Analytics. As we continue to expand our capabilities, we are open to integrating more advanced technologies. Our values are patient-centric. We have a flat organizational structure that encourages creativity and accountability. We offer a competitive salary, employee stock option plan, and provide career development opportunities within a fast-growing company. We've supported over 14,000 patients and 2,200 physicians, earning the trust of 50+ Biopharma companies. Join us in shaping the future of treatment access! We are a fast growing company with multiple rounds of funding. We provide equal opportunities and support our team members.

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๐Ÿ“ United States

๐Ÿงญ Full-Time

๐Ÿ” Health Tech

  • Bachelorโ€™s or Masterโ€™s degree in Life Sciences or similar.
  • At least 7 years of work experience in regulatory and pharmacovigilance roles in biotech/pharma, including specific experience in managing global expanded access programs.
  • In-depth knowledge of FDA and EU regulations, GMP and ICH guidelines and ability to implement them within the context of expanded access programs.
  • Experience in effectively managing expanded access teams, including external vendors.
  • Proven experience in mastering effective communication and negotiation skills internally and with regulatory authorities
  • Ability to organize, mentor and motivate the team in a quickly growing and agile/flexible environment
  • Ability to prioritize activities to ensure spending time on the critical priorities, with the highest impact on the organization
  • Ability to plan your work strategically coupled with a high willingness to also take action yourself
  • Proven ability to solve complex issues, get to the root cause, foresee potential issues, and proactively mitigate before they happen.
  • Lead the Regulatory Affairs & Pharmacovigilance team.
  • Develop, structure, and execute regulatory strategies of EAPs.
  • Act as Subject-Matter Expert for Regulatory Affairs and Pharmacovigilance.
  • Manage all Regulatory and Pharmacovigilance aspects of EAPs.
  • Consult clients on strategy for setting up and executing EAPs globally and/or in specific countries.
  • Structure and maintain an up-to-date working knowledge of Regulatory and Pharmacovigilance regulations and guidelines related to Expanded Access.
  • Support, control, and manage the Pharmacovigilance services offered to clients
  • Be responsible for the creation, review and maintenance of SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective Actions and Preventive Actions) assigned to the department
  • Support the Commercial team on the feasibility and qualification of new Expanded Access Programs
  • Provide team members with strong leadership, nurture personal development, and ensure a high-performance environment

LeadershipProject ManagementCross-functional Team LeadershipOperations ManagementCommunication SkillsAnalytical SkillsComplianceTeamworkClient relationship managementQuality AssuranceRisk ManagementTeam managementStrategic thinkingEnglish communicationBudget management

Posted 11 days ago
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๐Ÿ“ India

๐Ÿงญ Full-Time

๐Ÿ” Health Tech

  • Have a (bio)medical degree or background
  • +2 years of relevant work experience in Healthcare or Life Sciences.
  • Hold excellent verbal and written communication skills in English and Hindi.
  • Proficient in Microsoft Office tools, with a focus on Excel
  • Are self-motivated, adaptable, and thrive in a fast-paced environment where change is continuous
  • Serving as the first point of contact for physicians and their supportive staff throughout the EAP process and coordinating communication with external stakeholders including physicians, pharmacists, clinical trial coordinators, and sponsors in India.
  • Facilitating document exchange and processing HCP patient requests for medicinal products.
  • Managing customer management tools including processing patient data into the Electronic Data Capture (EDC) system(s) as needed and generating client reports where required.
  • Reviewing documents/data collection, identifying discrepancies, and collaborating with sites to fulfill regulatory requirements.
  • Collaborating closely with cross-functional teams within our Expanded Access Operations unit (e.g., Regulatory Affairs, Quality, Program Management, Supply Chain) to ensure smooth operations.
  • Drafting and updating program documentation leveraging existing departmental templates and/or designing new templates.
  • Supporting Program Managers (PMs) with oversight and maintenance of electronic Master Files and improving program processes.
  • Communicating with clients and maintaining a high-level of client satisfaction.

Operations ManagementCommunication SkillsAnalytical SkillsMicrosoft ExcelCustomer serviceAttention to detailOrganizational skillsTime ManagementWritten communicationMultitaskingInterpersonal skillsExcellent communication skillsAdaptabilityRelationship buildingProblem-solving skillsAccount ManagementTeamworkResearchFluency in EnglishActive listeningClient relationship managementStrong communication skillsCross-functional collaborationData entryRelationship managementQuality AssuranceStakeholder managementProcess improvement

Posted 13 days ago
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๐Ÿงญ Full-Time

๐Ÿ” Healthcare

  • 5+ years of experience within the pharmaceutical industry / CROs
  • Knowledge regarding Expanded Access is a plus
  • Experience with fostering positive sustainable business relationships and promoting value through excellent customer experience, networking
  • A good eye for detail; thinking in processes/operations comes naturally to you
  • Excellent verbal and written communication in English
  • Be the primary contact for our Biopharma clients and myTomorrows internal stakeholders for the Expanded Access Programs under your responsibility
  • Ensure a smooth-running program and correct documentation and reporting
  • Manage both planned and unforeseen additions to the program to ensure that people have access to the treatments they need
  • Keep oversight of the program at all times and manage all the ongoing activities and communication
  • Create detailed timelines including deliverables, milestones and objectives and ensure that deadlines are being met
  • Develop strong relations and trust with all stakeholders, and keep them up to date on the progress of your program
  • Achieve and maintain high customer satisfaction
  • Develop solutions to tackle any operational issues along with relevant subject-matter experts
  • Contribute to continuously improving our Expanded Access Program processes and strategies
Posted 14 days ago
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