Title: Medical Director, Gastrointestinal and Inflammation (Remote) Locations;Massachusetts - Virtual Worker Type;Employee Worker Sub-Type;Regular Time Type;Full time Job Description: Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Gastrointestinal & Inflammation in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Principal responsibilities include: - Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. - Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. - Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders. - Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products. POSITION ACCOUNTABILITIES: - Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature. - Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products. - Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. - Ensure communication of all safety information that may impact the benefit-risk profile of assigned products to senior management. - Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues. - Provide patient safety input to the clinical development program for assigned products and development compounds, and represent GPSE on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable. - Manage benefit-risk profile, including authoring and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products. - Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal. - Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory inquires, MAAs, NDAs, and BLAs. - Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents. - Demonstrate knowledge of local and global health authority requirements. - Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations. - Train and mentor Pharmacovigilance Physicians and Specialists. - Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: - M.D. or D.O. or internationally recognized equivalent, with direct clinical experience in patient care following post-graduate training and appropriate grounding and knowledge of general medicine. Board certification and licensure preferred. - At least 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products. - At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management. - Knowledge and understanding of national and international PV and regulatory guidelines. Travel Requirements: - Local and international travel across Takeda sites may be required. This position is currently classified as " remote" in accordance with Takeda's Hybrid and Remote Work policy. Empowering Our People to Shine No Phone Calls or Recruiters Please.

Dravet Syndrome News Columnist Pensacola, Florida, United States | Columns | Contract | Fully remote Job Opening Details: Bionews, a digital news company dedicated to creating communities for patients with rare and chronic diseases and their caregivers, is looking for members of the Dravet syndrome community to join our freelance staff of patient and caregiver columnists on Dravet Syndrome News. A Bionews columnist is a patient or caregiver who shares about life with a rare or chronic disease. They write personal essays in a column format to inform, inspire, empathize, and advise. Their audience includes patients, caregivers, medical teams, and researchers. Columnists also write to a general audience interested in learning how to improve society's understanding and treatment of disease/disability communities. All columns are reviewed with a critical eye by professional editors who will work with columnists to smooth rough spots and help the columnist grow as a writer. This is a contract position. Please note you MUST be a member of the Dravet syndrome community -- caregiver preferred -- in order to apply for this position.  Responsibilities and Duties - Fulfill 1x weekly deadlines as agreed upon on hire. - Communicate efficiently with your managers and editors. - Submit 400-800 word drafts that adhere to Bionews policies and procedures. - Aside from exceptions, drafts should not take more than 45 minutes to edit. - Fulfill revisions as requested by editors in a timely manner. - Complete training assigned by Bionews HR. Experience Required - Prior experience with writing for an audience. - At least three months’ direct experience with having or caring for someone with Dravet syndrome. - Caregivers must be direct relatives, guardians, or spouses. Experience Preferred  - Experience in being professionally edited for publication. - Experienced in generating a blog or column. - Participation in support groups, internet forums, or community groups relevant to Dravet syndrome. Knowledge Required - Fundamentals of how Dravet syndrome works. Knowledge Preferred - The content needs or wants of the Dravet community. Skills Required - A swift and independent learner of Internet technology. - A creative mind capable of regularly generating unique content that appeals to target audiences. - Time management. - Advanced creative writing. Skills Preferred - Experience in using WordPress for content creation. - Experience with the Slack communication app. Abilities Required - Internet access and use. - Native or fluent English writing and reading abilities.

• Serves as Medical Reviewer for Individual Case Safety Reports (ICSRs). • Gathers, reviews, and evaluates scientific and clinical data. • Prepares and contributes medical safety content for regulatory documents. • Supports safety signal detection and evaluation activities. • Authors high-quality safety review documents and evaluations.

• Facilitate generation of, author, update, and/or review key documents • Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies • Provide scientific expertise for selection of investigator and vendors • Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol • Provide scientific and medical support throughout conduct of a clinical trial • Review, query, and analyze clinical trial data • Create clinical study or program-related slide decks for internal and external use • Build and maintain opinion leader/investigator networks • Identify continuous process improvement opportunities • Support budget planning and management