Associate / Medical Director Resume Samples

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M Johnston

Mekhi

Johnston

374 Loyce Flat

Dallas

+1 (555) 408 2359

374 Loyce Flat

Dallas

Phone

p +1 (555) 408 2359

Experience Experience

Phoenix, AZ

Associate Medical Director, Benefit

Phoenix, AZ

Macejkovic Inc

Phoenix, AZ

Associate Medical Director, Benefit

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

Chicago, IL

Associate Medical Director, Clinical R & D

Chicago, IL

Beahan-Price

Chicago, IL

Associate Medical Director, Clinical R & D

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

present

Philadelphia, PA

Associate Medical Director / Medical Director

Philadelphia, PA

Bednar-Cummings

present

Philadelphia, PA

Associate Medical Director / Medical Director

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

Education Education

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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15 Associate / Medical Director resume templates

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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