Associate / Medical Director Resume Samples

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MJ
M Johnston
Mekhi
Johnston
374 Loyce Flat
Dallas
TX
+1 (555) 408 2359
374 Loyce Flat
Dallas
TX
Phone
p +1 (555) 408 2359
Experience Experience
09/2015 present
Philadelphia, PA
Associate Medical Director / Medical Director
Philadelphia, PA
Associate Medical Director / Medical Director
09/2015 present
Philadelphia, PA
Associate Medical Director / Medical Director
09/2015 present
  • Conduct ongoing medical monitoring of clinical trials, including assistance determining subject eligibility, review of safety and efficacy data, and visits to clinical research sites
  • Assist with the strategic planning and execution (including study design, method selection, etc) of Phase I through IV global clinical trials
  • Analyze and interpret data expertly, and clearly communicate results both internally and externally
  • Contribute to and review clinical documents (slide presentations, protocols, clinical study reports, regulatory submission sections, investigator ’ s brochures, etc.)
  • Work collaboratively with other Medical Directors, and colleagues in Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, Clinical Science, and Regulatory Affairs
  • Work closely with Contract Research Organizations, Principal Investigators, key opinion leaders, and participate in interactions with US and EU regulators
  • Define, lead and execute the safety strategy within the asset development teams and product safety teams for products for which he/she is the Product Safety Team Lead or supporting
03/2010 04/2015
Chicago, IL
Associate Medical Director, Clinical R & D
Chicago, IL
Associate Medical Director, Clinical R & D
03/2010 04/2015
Chicago, IL
Associate Medical Director, Clinical R & D
03/2010 04/2015
  • Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision
  • Lead the development of a significant clinical development budget and effectively manage resources, funding and expenses
  • Attract and develop talent, coach and mentor others to higher levels of performance. Create an atmosphere of innovation and continual improvement
  • Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
  • Oversee quality, coordination and timeless of clinical sections of IND’s, Investigator Brochures, CTA’s , ISS’, ISE’s and clinical expert reports
  • Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL’s
  • Collaborate extensively with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and strategic input
05/2004 12/2009
Phoenix, AZ
Associate Medical Director, Benefit
Phoenix, AZ
Associate Medical Director, Benefit
05/2004 12/2009
Phoenix, AZ
Associate Medical Director, Benefit
05/2004 12/2009
  • Develop risk minimization measures including user testing/human factors testing
  • Serve as SME/consultant to Product Safety Team/Asset Development Team (PST/ADT) to advise on benefit-risk (B/R) assessments and risk management (RM) strategies to support drug development programs, new product marketing applications and marketed products. Work in a collaborative manner to facilitate incorporation of cross-functional perspectives into B/R assessments and RM strategies
  • Support preparation / updating of (Risk Management Plan) RMPs for assigned products; support affiliates with development of local RMPs/annexes
  • Develop global/US implementation strategy for risk minimization programs
  • Work in a collaborative manner with statistical colleagues to develop graphical displays of B/R assessments and advise teams on use of quantitative B/R analysis approaches
  • Update / algin, SOPs/WIs/processes across AbbVie to ensure seamless execution of BRM activities. Serve as SME to support development of tools and templates to execute BRM processes
  • Ensure development and maintenance of education and communication materials for BRM processes and activities
Education Education
Bachelor’s Degree in Public Health
Bachelor’s Degree in Public Health
Brigham Young University
Bachelor’s Degree in Public Health
Skills Skills
  • Strong leadership skills and the ability to influence at all levels of the organisation as well as with external customers
  • Excellent communication skills, including strong presentation skills
  • Fluent knowledge of English (spoken and written)
  • Good understanding of global healthcare systems and pharmaceutical markets as well as pharmaceutical codes of practice
  • Experience in establishing strong influential relationships with academic societies
  • Proficiency in computer skills
  • Excellent work ethic
  • Self-starter, hands on mentality and able to work in a team
  • Willingness to travel frequently
  • Flexible, independent, and proactive working style
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1

Associate Medical Director, Hospice Resume Examples & Samples

  • Responsible for the overall medical component of the care and treatment of terminally ill patients and their families
  • Attends IDG and collaborates with the Hospice Team to ensure that the medical needs of the patient are met by the attending physician, and to ensure pain and symptom management and control
  • Serves as medical resource to hospice staff, patients, families, and attending physicians regarding pain and symptom control management
  • Participates in resolution of interpersonal conflict and issues of clinical and ethical concerns
  • Provides Pre-election Evaluation and Counseling services
  • Participates in the on-call physician rotation support
  • Completes all job duties in a manner that meets the accepted standards of practice and the OptumCare Hospice & Palliative Care Policies and Procedures
  • Works collaboratively in a team approach with Hospice Staff to achieve goals
  • Current and unrestricted MD or DO license and DEA in the state of Colorado
  • 5 or more years of experience with adults facing complex and advanced illnesses
  • Current hospital privileges or ability to obtain privileges for hospital consults
  • Board Certification in a direct patient care medical specialty
  • Experience using an Electronic Medical Record (EMR)
  • Previous Hospice or Palliative care experience
  • Board Certification in Hospice and Palliative Medicine
2

Associate Medical Director, Oncology Resume Examples & Samples

  • With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues
  • Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs
  • Has responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables
  • Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned
  • May serve on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility
  • Contributes to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members
3

Associate Medical Director / Medical Director Resume Examples & Samples

  • Conduct ongoing medical monitoring of clinical trials, including assistance determining subject eligibility, review of safety and efficacy data, and visits to clinical research sites
  • Assist with the strategic planning and execution (including study design, method selection, etc) of Phase I through IV global clinical trials
  • Contribute to and review clinical documents (slide presentations, protocols, clinical study reports, regulatory submission sections, investigator ’ s brochures, etc.)
  • Work collaboratively with other Medical Directors, and colleagues in Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, Clinical Science, and Regulatory Affairs
  • Work closely with Contract Research Organizations, Principal Investigators, key opinion leaders, and participate in interactions with US and EU regulators
  • MD. Pharmaceutical development experience and/or experience as a research scientist in academia or other settings is a plus
  • Expertise in Neurological Disorders
  • Excellent verbal, interpersonal and written communication skills
  • A strong clinical and scientific background, preferably with industry drug development experience
  • Ability to function as a collaborative and hands-on clinical expert within a dynamic and fast-paced team environment with both internal and external (CRO) members
  • Experience working with study investigators and staff at clinical sites
  • Experience in clinical trial design and analysis of clinical trial data
  • Familiarity with thought leaders in different fields of Neurology
4

Associate Medical Director, Cystic Fibrosis Resume Examples & Samples

  • Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
  • Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
  • MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate background in a clinical field)
  • Board certification/eligibility in pulmonary, gastrointestinal medicine, infectious
5

Associate / Medical Director Resume Examples & Samples

  • MD, MB/BS or equivalent degree and strong medical knowledge, proven clinical experience managing neurology patients in hospital practice and Neurology Specialist
  • Significant experience within pharmaceutical industry, clinical trials or pharmaceutical medicine
  • Strong communication & presentation skills and is a strong team player
6

Associate Medical Director, Cystic Fibrosis Resume Examples & Samples

  • Board certification/eligibility in pulmonary or gastrointestinal medicine, or another relevant medical field, is highly desired; clinical Cystic Fibrosis experience is a plus
  • At least 3 - 5 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
  • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
  • Global clinical research experience and experience interacting with regulatory authorities is a plus
7

National Associate Medical Director Resume Examples & Samples

  • Travel nationally up to 50% of the time working with HouseCalls team members (NPs etc.) on quality performance and initiatives
  • Work jointly with an operations counterpoint towards execution on CDQI related initiatives such as risk adjustment and quality
  • Identify opportunities to improve risk and quality and work within a matrixed team (CDQI and HouseCalls) to lead and drive strategy
  • Assist in coordination of CDQI efforts with senior leadership across OptumCare, Optum, and Payers
  • Provide direct provider to provider & provider to staff (clinical and non-clinical) support on interpreting data and analytics
  • Provide clinical insight and leadership to develop programs that drive strategy and address opportunity around CDQI related topics such as risk adjustment and quality
  • Provide direct provider mentoring in 1:1, small group, and large group sessions over time as needed
  • Monitor the progress of providers and develop tailored strategies to improve performance
  • Provide clinical insight and consultation to other members of the CDQI team, and other parts of the organization on a variety of projects
  • Provides medico-administrative leadership
  • Participates in regulatory and accreditation activities, as applicable
  • Active, unrestricted physician license
  • 5+ years of clinical practice experience after completing residency training
  • Substantial experience in using electronic clinical systems in the payer setting
  • Excellent presentation skills for both clinical and non-clinical audiences
  • Practice-based, working knowledge/experience with CMS STARS or HEDIS or Risk Adjustment
  • Strong belief in EBM (Evidence Based Medicine)and familiarity with current medical issues and practices
  • Proficiency with MS Word, Outlook, and Excel
  • Experience in other MS programs
8

Associate Medical Director, Partner Markets Resume Examples & Samples

  • Lead & develop high quality, fully integrated CEE, MENA, Nordics and Turkey Medical Affairs activities in collaboration with the Region 4 Medical Director and in line with the overall Region 4 strategic plans
  • Ensure that the knowledge and skills of Region 4 colleagues as well as Jazz’s external partners, with respect to Jazz Pharmaceuticals’ products and the appropriate therapy area, are at the highest level
  • Provide a medical information service on behalf of the affiliate adhering to appropriate standards relating to compliance, PV and the necessary SOPs
  • Role model and exemplify Jazz Cultural values
  • Work closely with the Region 4 Medical Director to ensure the development and delivery of the CEE, MENA, Nordics and Turkey Medical Affairs strategy and country plans
  • Ensure the needs of the CEE, MENA, Nordics and Turkey markets are effectively communicated to partners in the EU/RoW regional office and ensure alignment with the EU/RoW strategy
  • Ensure systems, processes and ways of working are in place to facilitate
  • Effective execution of country medical plans
  • Expert scientific knowledge of appropriate Region 4 team members as well as Jazz’s external partners for the region
  • Effective Key Account Planning with cross functional internal and external partners
  • Effective planning and utilization of Region 4 Key Opinion Leaders
  • Data generation activities including Investigator Initiated Research
  • High standards with regards to PV, compliance and SOPs
  • Delivery of quality medical information to internal and external customers
  • Develop influential relationships with Region 4 Key Opinion Leaders
  • Support development of Jazz positioning as the scientific authority in the field of oncology and haematology and support National KOL advocacy through provision of scientific and clinical information
  • Jazz Values & compliance
  • Operate with ethics and integrity, follow the Jazz values
  • Ensure all compliance policies and procedures are followed and partners are acting appropriately when conducting business on behalf of Jazz
  • Abide by, and ensure an excellent knowledge and understanding of, all relevant Codes of Practice
  • Ensure that all elements of the strategic, tactical and medical affairs plans comply with the these Codes of Practice
  • Ensure the necessary local medical and legal approval of all relevant product materials and/or events are in place prior to commercial implementation
  • Ensure distributors follow the required and agreed reporting processes in place in the safety agreements
  • Minimum of 5 years Pharmaceutical Industry experience, ideally in a comparable role
  • Good understanding of global healthcare systems and pharmaceutical markets as well as pharmaceutical codes of practice
  • Must have experience of launching new products, market shaping and launch readiness activities
  • Strong leadership skills and the ability to influence at all levels of the organisation as well as with external customers
  • Self-starter, hands on mentality and able to work in a team
  • Proficiency in computer skills
  • Produce timely management reports, budget tracking and audit data
9

Associate Medical Director Physician Resume Examples & Samples

  • Counsels and educates patients and families about acute and chronic conditions or concerns
  • Formulates diagnostic and treatment plans and prescribes medications, therapies, and procedures
  • Interacts with Clinic Physicians and staff to ensure that patient needs are met in an efficient and medically appropriate manner
  • Provides prime management, oversight and development for major program and functional areas within OptumCare
  • Monitor ambulatory care and communicates to the leadership and providers to make recommendations in order to position the organization proactively to manage trends effectively
  • Develop and implement action plans, including clinical guidelines, to ensure clinically appropriate and efficient utilization of services
  • Provide and/or supervise the education, guidance, assistance, and feedback to primary care physicians and specialty panels to achieve appropriate cost-effective patient care
  • Promote the appropriate utilization of clinical programs to manage complex and/or catastrophic cases and promote positive health outcomes
  • Develops a broad understanding of the various data elements available to the organization, working closely with the IT and EHR departments
  • Ensures that data is being used consistently throughout the clinical department to improve patient outcomes
  • Analyze patient population data in order to assist CM and other clinical programs in engaging patients who would benefit most
  • Establish and foster strong working relationships with the health plan Providers
  • Oversight of medical policy, health and wellness programs, and population management initiatives
  • Active and unrestricted Arizona medical license
  • Current and unrestricted DEA certificate
  • 2 or more years of clinical practice in direct patient care
  • 1 or more years of medical management or administrative experience in a managed care setting
  • Certified Medical Director
10

Associate Medical Director, Sofia Resume Examples & Samples

  • Strong medical knowledge and strong analytical skills
  • Understanding of the drug development process
  • Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information, and problem solve
11

Associate Medical Director, Neuroscience Resume Examples & Samples

  • Drive clinical efforts to increase confidence in targets and ensure targets are optimally matched for neurodegenerative indications
  • Develop and lead innovative phase 0 approaches in AD, PD and MS for biomarkers and novel clinical endpoints (e.g. new digital health methodologies) to support early signs of efficacy approaches
  • Leverage precompetitive consortia and academic collaborations to advance pipeline goals
  • Work across the matrix to deliver robust target engagement/proof of mechanism strategies in the NS portfolio for both preclinical and clinical stages
  • Support companion diagnostic and other personalized medicine initiatives as needed. Work with development/commercial/regulatory teams to champion new technologies to examine drug efficacy and patient/physician interfaces
  • Provide clinical lead and medical monitor support for NS portfolio programs
12

Associate Medical Director Global Pharmacovigilance Resume Examples & Samples

  • As appropriate, being the compound(s) GSL
  • Intimate awareness of safety for his/her compound responsibilities, including any emerging safety concerns and risk/benefit profile
  • As appropriate, mentoring/involvement in a leadership capacity for complex and strategically important programs
  • Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs, etc
  • Critical thinking and analytical skills and ability to make high level decisions
13

Associate Medical Director, Tysabri Resume Examples & Samples

  • Minimum of 3 years of combined pharmaceutical industry and academic/clinical medicine expertise is required
  • Ability to understand and effectively communicate scientific medical and regulatory information. Excellent written and oral communication skills are imperative
  • Ability to anticipate and adapt to change while maintaining the momentum of an overall strategic plan, ability to work independently, to complete tasks in a timely fashion, and function in a rapid paced, high pressure environment
  • Ability to communicate well with health care professionals
  • Ability to establish strong relationships with peer groups, professional organizations, and other outside parties to further departmental and corporate objectives & goals. Experience with Neurology Key Opinion Leaders is preferred
14

EU / ROW Associate Medical Director Resume Examples & Samples

  • Support of EU/RoW Therapy Area Medical Affairs Team
  • Review and critically appraise scientific literature to identify key drivers that differentiate Jazz's Haematology/Oncology medicines and provide support and advice to medical and marketing groups in developing strategy and tactical implementation plans
  • Work closely with the EU/RoW Therapy Area Medical Director to support the development and execution of the EU/RoW medical affairs strategy and plans
  • Ensure the EU/RoW KOL and educational activities are of a high scientific quality and coordinated
  • Provide guidance regarding appropriate speakers for EU/RoW congresses and workshops in order to expand and enhance scientific exchange
  • The incumbent will develop and maintain a high level of knowledge of Haematology/Oncology and related scientific literature in order to position him/herself as an expert in the field
  • Provide scientific education and in-house training for MSLs and Key Account Managers and other appropriate staff as required
  • Support the development and implementation of the EU/RoW medical affairs strategy aligned to commercial growth drivers
  • Support development of strategies and programs to ensure internal and external readiness for new product launches
  • Data Generation and Publication Planning
  • Support development of publication plans covering EU/RoW data generation needs
  • Cross portfolio liaison with KOLs, investigators and scientists in-region who wish to conduct investigator sponsored or Jazz sponsored studies
  • Support the development and execution of study plans to provide post marketing data to support the portfolio of Jazz Haematology/Oncology products in phase IV, observational and pharmaco-economic studies
  • Support development of Jazz positioning as the scientific authority on acute leukaemias and transplant complications
  • Support development of EU/RoW KOL advocacy through provision of scientific and clinical information via the MSL team
  • Deliver non-promotional clinical/scientific presentations relating to Jazz’s portfolio and its development or differentiation as required
  • Attend appropriate scientific congresses to stay abreast of developments
  • Able to understand the detailed science and clinical aspects of the Haematology/Oncology portfolio
  • Excellent command of spoken English
  • Strong communication skills to facilitate collaboration at all levels of the organisation as well as with external customers
15

Associate Medical Director, Immunology Resume Examples & Samples

  • Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned
  • Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents
  • Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies
16

Associate Medical Director / Medical Director Resume Examples & Samples

  • Define, lead and execute the safety strategy within the asset development teams and product safety teams for products for which he/she is the Product Safety Team Lead or supporting
  • Contribute to the strategy and authorship of key pharmacovigilance documents including but not limited to new drug application clinical safety summaries, White papers, regulatory responses, periodic safety update reports, safety sections of the investigator brochure, informed consent safety risk language, and the benefit risk plan and assessment
  • Execute signal detection and evaluation for assigned products in collaboration with Medical analytics
  • Risk assessment and management –develop risk management plans and REMS and apply current regulatory guidance for risk minimization, as appropriate
  • Oversee implementation of the risk management strategy for assigned products
  • Understand assigned products’ pharmacology and mechanism of action from a safety perspective, relevant nonclinical toxicology data and clinical AE profile
  • Familiarity with individual case safety reports for assigned products and in depth knowledge of the aggregate safety data across clinical trials
17

Associate Medical Director ACH Pediatric Resume Examples & Samples

  • Provide leadership and support for the development and implementation of a cohesive approach to measuring and promoting quality and support priority-setting process for clinical quality improvement for MassHealth’s payment and care delivery innovation initiatives, including ACOs and CPs
  • Assist the Director of OCA, the Medical Directors and the Chief of Payment and Care Delivery Innovation with the development and implementation of a holistic strategy to clinical, quality and analytics initiatives
  • Participate in or lead Advisory Board meetings and other OCA, EOHHS and Office of Medicaid meetings as designated by OCA Director or his/her designee
  • Provide clinical leadership and mentoring for the OCA and MassHealth staff and work collaboratively with both clinical and non-clinical team members
  • Build and maintain effective working relationships with cross-functional leaders and teams in order to identify, explore, present and implement clinical opportunities
  • Perform other similar and related duties as required or as directed
  • Medical Doctor or Doctor of Osteopathy
  • Board certified in area of specialty and minimum 5 years of experience in direct patient care
  • Must work onsite during normal business hours
  • Experience providing direct care to disabled populations or working in or with managed care organizations (e.g. ACO, PACE, SCO, or Integrated Care Organizations (ICOs)) serving these populations, including familiarity with long-term and other community services that support them
  • A graduate degree in Public Health or Public Policy or other advanced degree in business or healthcare is desirable
18

Associate Medical Director Acos Resume Examples & Samples

  • Provide clinical support and subject matter expertise to OCA programs and clinical staff, and provide clinical survey and certification and policies for MassHealth ACO and CP models
  • Collaborate with ACOs and CPs to support their efforts to improve utilization, quality of care, member experience, affordability, medical documentation, etc. for MassHealth members attributed to ACOs
  • Provide clinical leadership to the activities of medical program managers
  • Provide updates and consult with OCA and MassHealth managers on new technologies, treatment methodologies and policies
  • Participate in communications with MassHealth medical providers, conduct peer-to-peer discussions, as applicable, and educate physicians and others on current policy
  • Assist the Director of OCA and the Medical Directors with the development and implementation of clinical, quality and analytics initiatives. Participate in OCA activities to monitor, report upon, and make recommendations regarding quality, clinical effectiveness and cost effectiveness of MassHealth medical services and programs
  • Actively licensed to practice medicine without restriction in Massachusetts throughout his/her employment with OCA
  • Experience in the application of state and federal Medicaid rules and regulations
19

Ipodd Associate Medical Director Resume Examples & Samples

  • Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams)
  • Supports other CST members with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
  • Participates in meetings, reviews, discussions and other interactions regarding clinical studies to provide clinical science development input and guidance
  • Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings
  • Provides clinical support across all relevant studies and programs
20

Associate Medical Director, Clinical R & D Resume Examples & Samples

  • Oversee quality, coordination and timeless of clinical sections of IND’s, Investigator Brochures, CTA’s , ISS’, ISE’s and clinical expert reports
  • The ability to establish, communicate and drive a vision and strategy for the therapy area/product and develop and integrated plan of action including milestones and endpoints and ensure executional excellence
  • Viewed as a global leader with the therapeutic area/disease state and considered a scientific contributor and innovator within internal and external spheres of influence
  • Attract and develop talent, coach and mentor others to higher levels of performance. Create an atmosphere of innovation and continual improvement
  • Minimum M.D. degree and medical/clinical training in Hematology/Oncology
  • 2-3 years of experience designing, leading and managing significant clinical trials in Hematology/Oncology Direct industry experience is preferred; experience working on industry-sponsored trials will be considered
  • Champion employee development training
  • Handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies
21

Associate Medical Director, Stroke Resume Examples & Samples

  • Lead specific data generation projects to address identified medical data gaps
  • Provide medical expertise to cross-functional teams. As a content expert, review abstracts, publications, medical information letters, and other medical documents as needed
  • Collaborate with regional and/or affiliate medical to ensure regional activities are aligned with global medical strategy and that Global Medical is sufficiently aware of affiliate and regional insights and needs
  • Effectively interacts and collaborates at multiple levels in the organization, including effective cross-functional interface with Regional and Affiliate Medical, R&D, Commercial, and Program Leadership
  • Experience with neurology or acute care is a plus
  • Launch experience is a plus
  • Excellent communication (particularly both written and oral), leadership, and presentation skills
22

Associate Medical Director, Benefit Resume Examples & Samples

  • Serve as SME/consultant to Product Safety Team/Asset Development Team (PST/ADT) to advise on benefit-risk (B/R) assessments and risk management (RM) strategies to support drug development programs, new product marketing applications and marketed products. Work in a collaborative manner to facilitate incorporation of cross-functional perspectives into B/R assessments and RM strategies
  • Work in a collaborative manner with statistical colleagues to develop graphical displays of B/R assessments and advise teams on use of quantitative B/R analysis approaches
  • Support preparation / updating of (Risk Management Plan) RMPs for assigned products; support affiliates with development of local RMPs/annexes
  • Understand assigned products' pharmacology and benefit/risk profile; understand precedence analysis and apply to (Benefit-Risk Management) BRM deliverables
  • Prepare and/or review B/R and RM sections in clinical development, pharmacovigilance or regulatory documents
  • Drive buy-in, adoption, and compliance with BRM processes across AbbVie
  • Develop risk minimization measures including user testing/human factors testing
  • Develop global/US implementation strategy for risk minimization programs
  • Develop effectiveness evaluations for a risk minimization measures/programs; apply evaluation outcomes to define corrective measures when needed
  • Work in a collaborative manner with office of Quality Person PV (QPPV) to ensure affiliate compliance with execution of RM strategies
  • Ensure development and maintenance of education and communication materials for BRM processes and activities
  • Evaluate impact of new PV legistlation on BRM activities
  • Participate in pharmacovigilance/cross-functional or external initiatives to develop and implement policies and procedures (aligning with requirements of regulatory authorities, global polices and best practices) relating to BRM
  • Support preparation of publications relating to BRM processes and activities
  • Anticipate emerging issues and develop solutions relating to BRM processes and deliverables
  • Support inspection readiness activities
  • Update / algin, SOPs/WIs/processes across AbbVie to ensure seamless execution of BRM activities. Serve as SME to support development of tools and templates to execute BRM processes