Medical Director, GDS
3 weeks ago
This is what you will do:
The Medical Director, Global Patient Safety (GPS)is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion’s products by patients and healthcare providers.
The Medical Director will be responsible for safety activities for investigational products and/or marketed, including
identification and evaluation of safety signals and risk management to drive decision-making on risk/benefit evaluation.
The Medical Director, Global Patient Safety will be supervised by Senior/Executive Director, Global Patient Safety
.
You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:
Through data review and research, identifying for monthly Safety, Risk Management and Safety Science Management Team meetings, issues that could be potential signals for observed adverse events for further review and analysis
Chairing and/or directing the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closure
Representing Alexion Global Patient Safety at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetings
Detecting, validating, and managing pre-and/or post-approval safety signals through to resolution
Conducting medical review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes in process
Evaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required
Identifying, initiating, and managing to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary
Overseeing safety sections of documents and safety interactions with Regulatory authorities. This may include: authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs
You will need to have:
MD or equivalent degree or
a life
sciences/pharmacy/nursing
degree,
and demonstrated Patient Safety and/or Clinical/ Drug Development experience
Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
The ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projects
Knowledge and understanding of GPS deliverables, standards and processes
Knowledge and understanding of US and EU safety regulations pre- and post- marketing
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic
messaging;engage
in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
2-3 years relevant safety and risk management experience in the pharmaceutical, biotech or CRO industry
Rare, Ultra-Rare or Orphan Disease Area experience
Strong verbal and written communication skills including making recommended courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions
Excellent, independent judgment based on knowledge and expertise
Strong personal time-management and project-management skills
Mastery of Microsoft Word, PowerPoint and Excel
#LI-RM1
#J-18808-Ljbffr
-
Medical Director, GDS
1 month ago
Boston, United States Alexion Pharmaceuticals, Inc. Full timeThis is what you will do: The Medical Director, Global Patient Safety (GPS) is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The Medical Director will be...
-
Medical Director, GDS
16 hours ago
Boston, United States Alexion Pharmaceuticals, Inc. Full timeThis is what you will do: The Medical Director, Global Patient Safety (GPS) is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The Medical Director will be...
-
Medical Director, GDS
2 months ago
Boston, MA, United States AstraZeneca GmbH Full timeThis is what you will do: The Medical Director, Global Patient Safety (GPS)is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion’s products by patients and healthcare providers. The Medical Director will be...
-
Director of Psychiatry- Medical Director
2 months ago
Boston, MA, United States Boston Medical Center Full timeMedical Director of Addiction Psychiatry Treatment Program (APTP) Boston University School of Medicine, Department of Psychiatry As an academic institution at Boston Medical Center, active engagement in research and education is encouraged with new resources available for program development and scholarly pursuits. Education/supervision opportunities are...
-
Medical Device
1 week ago
Boston, United States Elucent Medical, Inc. Full timeJob Title: Area Director Reports to: Chief Commercial OfficerEDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS· Bachelor’s degree· Five years of Medical Device Experience and/or business-to-business sales experience required· Capable of standing for multiple hours at a time · Capable of lifting up to 50 pounds on occasion· OR experience...
-
Medical Device
1 week ago
Boston, United States Elucent Medical, Inc. Full timeJob Title: Area Director Reports to: Chief Commercial OfficerEDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS· Bachelor’s degree· Five years of Medical Device Experience and/or business-to-business sales experience required· Capable of standing for multiple hours at a time · Capable of lifting up to 50 pounds on occasion· OR experience...
-
Medical Device
1 day ago
Boston, United States Elucent Medical, Inc. Full timeJob Title: Area Director Reports to: Chief Commercial OfficerEDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS· Bachelor’s degree· Five years of Medical Device Experience and/or business-to-business sales experience required· Capable of standing for multiple hours at a time · Capable of lifting up to 50 pounds on occasion· OR experience...
-
Medical Device
6 hours ago
Boston, United States Elucent Medical, Inc. Full timeJob Title: Area Director Reports to: Chief Commercial OfficerEDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS· Bachelor’s degree· Five years of Medical Device Experience and/or business-to-business sales experience required· Capable of standing for multiple hours at a time · Capable of lifting up to 50 pounds on occasion· OR experience...
-
Medical Director Of Practice
1 week ago
Boston, United States Codman Square Health Center Full timeJob Details Job Location Codman Square Health Center - Dorchester, MA Position Summary: Codman Square Health Center's mission is to be a resource for the physical, mental and social well-being of our community. The Health Center strives to deliver services that support the achievement of its mission, while creating a sustainable care model that adapts to the...
-
Sr. Medical Director, MassHealth
1 month ago
Boston, United States University of Massachusetts Medical School Full timeOverview Under the general direction of the Director of the Office of Clinical Affairs (OCA)/Chief Medical Officer or designee, the Sr. Medical Director MassHealth:• Supports the designated MassHealth programs such as Payment and Care Delivery Innovation.• Develops, implement and support program and policies to improve clinical performance through...
-
Sr. Medical Director, MassHealth
1 day ago
Boston, United States University of Massachusetts Medical School Full timeOverview Under the general direction of the Director of the Office of Clinical Affairs (OCA)/Chief Medical Officer or designee, the Sr. Medical Director MassHealth:• Supports the designated MassHealth programs such as Payment and Care Delivery Innovation.• Develops, implement and support program and policies to improve clinical performance through...
-
Sr. Medical Director, MassHealth
3 weeks ago
Boston, United States University of Massachusetts Medical School Full timeOverview: Under the general direction of the Director of the Office of Clinical Affairs (OCA)/Chief Medical Officer or designee, the Sr. Medical Director MassHealth: Supports the designated MassHealth programs such as Payment and Care Delivery Innovation. Develops, implement and support program and policies to improve clinical performance through MassHealth...
-
Director, Medical Affairs
1 week ago
Boston, United States Verve Therapeutics Inc Full timeThe Position The Director of medical affairs will be responsible for contributing to the overall medical affairs strategy and executing tactical plans. Priority activities include publications and medical communications, scientific congress execution, internal training materials development and delivery, and medical education programming. The Director will...
-
Director, Medical Affairs
17 hours ago
Boston, United States Verve Therapeutics Inc Full timeThe Position The Director of medical affairs will be responsible for contributing to the overall medical affairs strategy and executing tactical plans. Priority activities include publications and medical communications, scientific congress execution, internal training materials development and delivery, and medical education programming. The Director will...
-
Boston, United States Boston Medical Center Full timeMedical Director of Addiction Psychiatry Treatment Program (APTP) Boston University School of Medicine, Department of Psychiatry SUMMARY: The position involves outpatient care of individuals with substance use disorders, including working to support patient engagement with medication for substance use disorders within a nurse care manager model. As an...
-
Associate Medical Director, OLTSS
1 month ago
Boston, United States University of Massachusetts Medical School Full timeOverview The Associate Medical Director (AMD) for MassHealth's Office of Long Term Services & Supports (OLTSS), under the direction of the Director of the Office of Clinical Affairs (OCA) or designee, is responsible for providing clinical expertise to OCA and to the MassHealth program staff in the areas of LTSS. MassHealth, the Commonwealth of...
-
Associate Medical Director, OLTSS
16 hours ago
Boston, United States University of Massachusetts Medical School Full timeOverview The Associate Medical Director (AMD) for MassHealth's Office of Long Term Services & Supports (OLTSS), under the direction of the Director of the Office of Clinical Affairs (OCA) or designee, is responsible for providing clinical expertise to OCA and to the MassHealth program staff in the areas of LTSS. MassHealth, the Commonwealth of...
-
Contract Medical Director
1 week ago
Boston, United States Lprs Full timeWe are looking for a Contract Medical Director. This is a great place to grow your career. You'll be glad you applied Responsibilities Fully understand the internal processes of all departments Participate in the recruitment of new physicians and other medical staff Stay up to date on medical trends Perform all other related duties as assigned Qualifications...
-
Boston, United States Boston Medical Center Full timeMedical Director of Addiction Psychiatry Treatment Program (APTP) Boston University School of Medicine, Department of Psychiatry SUMMARY: The position involves outpatient care of individuals with substance use disorders, including working to support patient engagement with medication for substance use disorders within a nurse care manager model. As an...
-
Director, Medical Director
7 days ago
Boston, MA, United States Jobot Full timeGrowing Primary Care Community Health Org is Looking for a Primary Care Medical Director MD/DO Are you a Family or Internal Medicine Physician Looking for a Leadership Opportunity? Do you want to work for a highly regarded outpatient healthcare organziation in Boston? Are you passionate about helping underprivileged people? Do you like giving back to...