Medical Affairs Director
2 weeks ago
We are seeking a highly skilled Senior Manager, Medical Excellence to join our team at ONO PHARMA USA. This is a key leadership position that will play a critical role in designing and developing the US Medical Affairs capability strategy and execution.
Key Responsibilities- Drive medical excellence of US Medical Affairs members for both Head Office and Field teams, and build capabilities within US Medical Affairs to enable high-level performance.
- Optimize medical affairs processes, improve scientific communication, and drive strategic initiatives to enhance the effectiveness and impact of the medical function within the organization.
- Ensure knowledge transfer and medical education utilizing the appropriate platforms and channels (CME, IME), including vendor and provider management.
- Design and development of the US Medical Affairs capability strategy and execution, to enable US Medical Affairs team to perform at a high level.
- Identify optimal metrics and KPIs to measure the impact of the US medical team.
- Responsible for ensuring timely and accurate financial/budgetary tracking in collaboration with Medical Head and other function leaders in Medical Affairs.
- Own department vendor, agency, and consultant relationships, including all negotiations, contracting, and payments.
- Identify technical needs and partner with IT department to ensure the appropriate IT tools are available and optimized for the field team and the Head office team.
- Responsible for primary system administration support for all department IT tools.
- Develop US Medical Affairs policies, and Standard Operating Procedures (SOPs).
- Is the content and process owner for medical content reviewed by MLR.
- Establish Med info infrastructure and manages process.
- Optimize medical affairs processes, improve scientific communication, and drive strategic initiatives to enhance the effectiveness and impact of the medical function within the organization.
- Drive Medical Affairs digital & IT innovation.
- Ensure knowledge transfer and medical education utilizing the appropriate platforms and channels (CME, IME), including vendor and provider management.
- Oversee Medical Communication & Education processes, serving as primary contact with respective global team and external vendors.
- Partner closely with Finance department with developing, maintaining, tracking, and managing department budget.
- Partner closely with legal & compliance department through contracting process.
- Work closely with MLR review committee to ensure all Medical content is reviewed on a timely basis.
- Collaborate closely with commercial colleagues in preparation for Medical Congress activities.
- Bachelor's degree is required; Bachelor of Science preferred.
- 5 years US pharmaceutical industry experience.
- Experience in a matrix, cross-functional environment.
- Knowledge of US compliance rules in respect to Medical Affairs activities.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Adept in contracting and budget management.
- Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources to achieve desired outcomes.
- Excellent communication and presentation skills.
- Ability to effectively present to and connect with the members of a diverse audience.
- Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g. in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).
- The noise level in the work environment is usually quiet.
- This role requires the incumbent to travel up to 20% of the time.
-
Medical Director, Medical Affairs
7 hours ago
Cambridge, Massachusetts, United States AbbVie Full timeJob SummaryAbbVie is seeking a highly skilled Medical Director or Scientific Director to join our Medical Affairs team. As a key member of our team, you will be responsible for providing strategic medical and scientific input into core medical affairs activities, including healthcare professional/provider interactions, generation of clinical and scientific...
-
Medical Affairs Director for Rare Diseases
4 days ago
Cambridge, Massachusetts, United States US Tech Solutions Full timeJob Title: Medical Affairs Director for Rare DiseasesUS Tech Solutions is seeking a highly skilled Medical Affairs Director for Rare Diseases to join our team.Job Summary:The Medical Affairs Director for Rare Diseases will provide support to all US medical affairs activities related to rare diseases. This role will involve working closely with...
-
Medical Affairs Director for Rare Diseases
2 weeks ago
Cambridge, Massachusetts, United States US Tech Solutions Full timeJob DescriptionUS Tech Solutions is seeking a highly skilled Medical Affairs Director for Rare Diseases to join our team.Location: Cambridge, MA / HybridDuration: 6 months contractThe Director, Medical Affairs Rare Disease will provide support to all US medical affairs activities related to the Rare Disease Live. Key responsibilities include:Providing...
-
Medical Affairs Director for Rare Diseases
6 days ago
Cambridge, Massachusetts, United States US Tech Solutions Full timeJob Title: Medical Affairs Director for Rare DiseasesUS Tech Solutions is seeking a highly skilled Medical Affairs Director for Rare Diseases to join our team. As a key member of our Medical Affairs department, you will be responsible for providing strategic medical insight and operational input into core medical affairs activities.Responsibilities:Develop...
-
Director of Dermatology Medical Affairs
2 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeAbout the RoleWe are seeking a highly skilled and experienced Director of Dermatology Medical Affairs to join our team at Takeda. As a key member of our US Medical Affairs organization, you will be responsible for developing and executing medical strategies for our dermatology products.Key ResponsibilitiesDevelop and execute medical strategies for assigned...
-
Medical Director Alzheimer's US Medical Affairs
2 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob Title: Medical Director, Alzheimer's, US Medical AffairsBiogen is seeking a highly skilled Medical Director to lead the development and execution of the US medical strategy for Alzheimer's. As a key member of the US Specialty Care Medical Director office team, you will be responsible for supporting the development and implementation of the US Medical...
-
Cambridge, Massachusetts, United States Biogen Full timeJob Title: Medical Director, Alzheimer's, US Medical AffairsBiogen is seeking a highly skilled Medical Director to lead the development and execution of the US medical strategy for Alzheimer's. As a key member of the US Specialty Care Medical Director office team, you will be responsible for supporting the development and implementation of the US Medical...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Senior Director, Global Medical Affairs StrategyBicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Our company is evaluating zelenectide pevedotin, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a...
-
Cambridge, Massachusetts, United States AAPC Full time{"Job Title": "Associate Director, Medical Affairs, Adult Cholestatic Diseases", "Job Summary": "We are seeking a highly skilled Associate Director to join our Medical Affairs team in Cambridge, MA. As a key member of our team, you will be responsible for contributing to the medical strategies and overall US medical affairs plan for adult cholestatic...
-
Regulatory Affairs Director
1 week ago
Cambridge, Massachusetts, United States PSG Global Solutions Careers Full timeAssociate Director of Regulatory Affairs Job DescriptionAt PSG Global Solutions Careers, we're seeking a highly skilled Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market.Develop and...
-
Regulatory Affairs Director
5 days ago
Cambridge, Massachusetts, United States GlaxoSmithKline Full timeJob Title: Regulatory Affairs DirectorGlaxoSmithKline is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regional regulatory strategies to ensure compliance with internal GSK processes and regional regulatory requirements.Key...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full timeJob DescriptionBicycle Therapeutics Limited is seeking a highly skilled Senior Director, Global Medical Affairs Strategy to join our team. As a key member of the Medical Affairs leadership team, you will be responsible for developing and executing the overall global medical affairs strategy and tactical plans for our current and future portfolio.Key...
-
Senior Director of Clinical Affairs
4 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleSenior Director of Clinical AffairsJob SummaryWe are seeking a highly experienced and skilled Senior Director of Clinical Affairs to join our team at Philips. As a key member of our organization, you will be responsible for delivering clinical knowledge, experience, and expertise across the entire value chain from ideation to end-of-life.Key...
-
Cambridge, Massachusetts, United States Biogen Idec Full timeAbout This RoleThe Medical Director – Alzheimer's role is a key position within Specialty Care, North America (US) Medical, a strategic partner within Biogen that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes.ResponsibilitiesLead the long-range planning, development, and execution of the US...
-
Director of Global Regulatory Affairs
6 days ago
Cambridge, Massachusetts, United States GlaxoSmithKline Full timeJob Title: Director, Global Regulatory AffairsGlaxoSmithKline is seeking a highly skilled and experienced Director, Global Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and leadership on regulatory matters related to our RNA vaccines.Key...
-
Cambridge, Massachusetts, United States AAPC Full timeJob Title: Associate Director Medical Affairs Adult Cholestatic DiseasesCompany: Ipsen Biopharmaceuticals IncLocation: Cambridge, MA, United StatesJob Description:Job Summary:The Associate Director Medical Affairs Adult Cholestatic Diseases will support and oversee some of the medical affairs activities of the adult cholestatic therapeutic areas. This role...
-
Cambridge, Massachusetts, United States AAPC Full timeAbout the RoleWe are seeking a highly skilled Associate Director, Medical Affairs, Adult Cholestatic Diseases to join our team at AAPC. As a key member of our Medical Affairs department, you will play a critical role in supporting and overseeing medical affairs activities for adult cholestatic therapeutic areas.Key ResponsibilitiesContribute to and lead...
-
Director, Regulatory Affairs CMC
3 weeks ago
Cambridge, Massachusetts, United States Takeda Full timeRegulatory Affairs Director, Small MoleculesTakeda is seeking a highly experienced Regulatory Affairs Director, Small Molecules to lead our Global Regulatory Affairs CMC team. As a key member of our team, you will be responsible for overseeing the development and execution of regulatory CMC development and registration strategies.Key Responsibilities:Plan,...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full time{"title": "Regulatory Affairs Director", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will be responsible for establishing and communicating regulatory strategies for development programs and coordinating the timelines, generation, and...
-
Regulatory Affairs Director
1 week ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.Job DescriptionThe Director/Senior Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy....
