Global Medical Affairs Resume Sample
Elisabeth Schuppe
673 Lind Squares,
San Francisco,
CA
+1 (555) 987 5955
Work Experience
Senior Global Medical Affairs Leader
08/2016
-
PRESENT
Phoenix, AZ
- For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input to, e.g.
- Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, etc...
- Lead content development and presentation for external medical education programs, and other Global Medical initiatives
- Develop, conduct, or participate in therapeutic training programs for Alexion personnel
- Medical affairs review of field medical tools, internal commercial training material. - Pending MLR Workstream recommendations
- Independent review of Medical Grant requests including CME, symposia and others
- Medical affairs review of post approval regulatory responses and annual safety reports
- Medical affairs review of reimbursement dossiers
Global Medical Affairs
07/2012
-
03/2016
Phoenix, AZ
- Medical affairs review of congress abstracts and publications
- Work with the Franchise Medical Team Lead and Global Medical Affairs Team to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
- As delegated by the Franchise Medical Team Lead, lead functional (e.g. publications, medical communications, medical training) and in-line R&D teams in developing plans supporting global medical strategy
- As delegated by the Franchise Medical Team Lead, collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution
- As delegated by the Franchise Medical Team Lead, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Product Strategy Team
- Support the development, execution and communication of the global medical affairs strategy of the (Product) Global Medical Affairs Team (GMAT) to maximize Amgen’s value proposition
- Support the development and execution of global medical affairs strategy, including external stakeholder management, communication, evidence generation, and medical education
- Support the development and execution of evidence generation strategy, including Investigator Sponsored Studies. Support regions/ local geographies in ensuring their evidence generation strategies are aligned to global
- Support the development and execution of a global medical communication strategy including Clinical narrative framework, Scientific platform, Core content, Congresses, Publications. Ensure consistency of clinical content and scientific messages across publications and materials
Senior Global Medical Affairs Leader
01/2007
-
04/2012
Los Angeles, CA
- Support external stakeholder engagement strategy to strengthen external understanding of the unmet need and medical value of the product to appropriate patients (OLs, Advocacy groups, Patient affairs, Medical societies, payers)
- Support the development and execution of medical educational strategy
- Support the Global Brand Team in the brand planning process to ensure alignment between medical and brand activities, and help providing interpretation of clinical study data
- Support the build-up of Amgen’s reputation as a science-based and patient focused reliable partner
- Elaborate on the current standard of care (SOC) for the target diseases by developing and executing Global Medical Research (GMR) strategies (IST program, registry, other phase IV when needed) as well as performing opportunity and gap analyses
- Contribute to the development and execution of the GMSA operating plan supporting a strong and efficient department infrastructure
- Represent supported projects at scientific and medical conferences and advisory committees
- Attend and contribute to relevant scientific and medical conferences to assist in strategy development and further develop Key Opinion Leader (KOL) interactions
Education
Union Institute and University
2002 - 2006
Science's Degree in Science
Professional Skills
- Flexibility and responsiveness-ability to anticipate change and adapt strategies to maintain program integrity and accomplish Takeda’s business objectives
- Excellent communication skills both written and oral, including strong presentation skills
- Strong strategic and leadership skills and preferably experience of managing priority brands
- Strong leadership skills and experience of managing priority brands
- Strong prioritization and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies
- Prior experience working with a field-based or Medical Science Liaison (MSL) team or prior MSL / MSL management experience is an advantage
- Manage competing priorities and projects, requiring an excellent ability to prioritize and manage expectations
How to write Global Medical Affairs Resume
Global Medical Affairs role is responsible for leadership, health, presentation, groups, reporting, finance, training, integration, database, security.
To write great resume for global medical affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Global Medical Affairs Resume
The section contact information is important in your global medical affairs resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Global Medical Affairs Resume
The section work experience is an essential part of your global medical affairs resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous global medical affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular global medical affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Global Medical Affairs resume experience can include:
- Strong leadership, team building, negotiation skills and ability to execute
- Entrepreneurial mindset and excellent execution skills
- Demonstrated experience in developing and implementing global or local medical strategies and tactics
- Demonstrated experience from running Scientific Steering Committees or Adboards
- Substantial experience in the industry, with experience of working within a Global Medical Affairs organisation
- Demonstrated experience in developing Global or local medical strategies
Education on a Global Medical Affairs Resume
Make sure to make education a priority on your global medical affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your global medical affairs experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Global Medical Affairs Resume
When listing skills on your global medical affairs resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical global medical affairs skills:
- Demonstrated ability to build collaborative working relationships and ability to function effectively in a matrix environment
- Experience in effectively managing risk and compliance issues
- Excellent communication skills (articulate and persuasive) to scientific and non-scientific groups
- Strong interpersonal skills to enable cross function and cross-business success
- Excellent presentation communication skills
- Proven ability to communicate and collaborate effectively with senior management and medical professionals
List of Typical Experience For a Global Medical Affairs Resume
1
Experience For Senior Global Medical Affairs Leader Resume
- Participate in the review of IST proposals in regional and global review meetings and oversee the scientific review of IST protocols; Lead the IST-related communication to key internal stakeholders in collaboration with the MSLs
- Build on existing networks and establish relationships with KOLs and community Health Care Providers (HCPs); communicate and interact with MSLs and KOLs in a compliant and ethical manner in accordance with relevant SOPs
- Highly innovative to drive a complex and changing environment and effectively manage and resolve issues within the therapeutic area is required
- MD, Pharm D or PhD preferably with experience in the field of Respiratory Medicine in lack of substantial industry experience
- Proven ability to engage, influence and build effective relationships with KEEs
2
Experience For Global Medical Affairs Leader Resume
- Management experience at progressing and increasingly complex/strategic levels
- Solid understanding of drug development and product life-cycle development
- Experience working in a cross-functional, matrixed environment both internally and externally
- Proven ability to work cross-functionally with a broad set of stakeholders from all functions of Global/local Medical Affairs and Commercial
- MD, Pharm D or PhD with experience in the field of Respiratory Medicine
- Solid knowledge of clinical development of Biologics preferably within Respiratory medicine
3
Experience For Head of Global Medical Affairs Resume
- Setting the long term strategy for VHC Medical Affairs and Governance Operations and Patient Affairs
- Participates in the evaluation of potential licensing candidates
- Contribute to global medical strategy through deep understanding of medical practice
- Support the development and execution of global medical affairs strategy including medical insight generation and translation into medical strategy
- Participate in GMSA, Commercial, Clinical and Drug safety teams as appropriate to PEGPH20
- Proactively stay abreast of current developments within the pertinent disease areas
4
Experience For Global Medical Affairs Director Resume
- Strong analytical and problem solving skills, self-motivated and capable of motivating others, creative and goal-oriented, can-do attitude with ability to achieve buy-in a matrix environment, a very good team player who can work effectively through teams to achieve results, leadership capabilities
- Educate internal Varian personnel and other relevant stakeholders (e.g. licensees and distributors) in the product's appropriate use
- Provide practical medical and clinical expertise and advice on the optimal integration of SIR-Spheres microspheres into multi-modality cancer care
- Patient-centred but commercially aware, values-driven approach
- High ethical standards required
- Assist in the management of Shire’s Global Independent Medical Education request management system
- Support development of the in-year medical tactical plan and budget for global initiatives and those in the United States
5
Experience For Global Medical Affairs Associate Resume
- As delegated by the GMA Head, Pipeline, lead functional (e.g. publications, medical communications, medical training) and Pipeline R&D/Product Strategy teams in developing plans supporting global medical strategy
- As delegated by the GMA Head Pipeline, collaborate with New Products and, when appropriate, the Product Strategy Team Lead (PSTL) to ensure aligned and medically appropriate commercial strategy, planning and execution
- As delegated by the GMA Head Pipeline, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Global Development Teams and Early Development Teams where appropriate. Transition to Product Strategy Teams and GMTs when appropriate
- Relevant experience in the pharmaceutical / nutrition industry
- Lead KOL stakeholders’ management inclusive of advisory boards, speaker bureaus etc…
- Global Medical ‘point of contact’ for the designated medicine(s) within the Pain franchise. Responsible for medical and scientific leadership and support to current and future commercialized medicines, and issues management for current medicines
- Coordination and execution of overall medical strategy for Teva’s Pain specialty brands in close collaboration with Regional Medical Affairs teams, from initiation of regional pre-launch activities to several years post-launch
- Global Medical ‘point of contact’ for the designated medicine(s) within the migraine & headache franchise. Responsible for medical and scientific leadership and support to current and future commercialized medicines, and issues management for current medicines
- Coordination and execution of overall medical strategy for Teva’s migraine & headache specialty brands in close collaboration with Regional Medical Affairs teams, from initiation of regional pre-launch activities to several years post-launch
6
Experience For Director, Global Medical Affairs, Lymphoma Resume
- Works closely with PVU, PVO, PVF colleagues to develop a shared accountability for each other’s successes through a deep understanding of shared objectives, behaviours and deliverables
- Demonstrable experience of governance activities and their pragmatic implementation in an integrity framework
- Senior Global Medical Affairs Physician’s primary purpose is to provide strategic medical direction and leadership to ensure the successful global commercialization and medical development of Bayer in products in oncology
- Provide medical review of promotional material from the Global Brand Team for global use e.g. product monographs, brochures, press releases, Q&A’s, field communications
- Experience in Medical Affairs or equivalent
- Build and manage the analytics function for DCV Medical Affairs, supporting US and Regional Medical and Field Based Medical teams, building processes and managing the analytics objectives; contributing overall to the following
- Previous related experience in the pharmaceutical industry (ideally in a medical affairs or clinical function)
- Design, conduct, drive and report progress on all Medical Affairs’ studies
7
Experience For Executive Director, Global Medical Affairs Resume
- Contribute to the development of key publications (abstracts, manuscripts, posters, presentations, etc) and assure they are consistent with the Company’s Strategy as outlined in the Publication Plan; accountable for publication sign-off
- Serve as a key member of the Business Development team, driving gap analysis, assessing opportunities, and advocating for specific projects that meet Company’ Strategy
- Able to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- Prior experience in pediatric field
- Previous experience in drug delivery systems helpful
- Establish and maintain strong relationships with experts in pediatric, Dermatology field, academics and professionals and/or patient associations
- Support the development and execution of global medical evidence generation strategy to shape medical practice, including investigator sponsored studies
- Provides input on feasibility of the product during pre-clinical and clinical studies
- Enable to lead and manage the entire Medical Affairs team and achieve both Company’s goals and team objectives on time
8
Experience For VP, Global Medical Affairs Resume
- Develops, produces, and organizes manuscripts, presentations, international symposiums, and posters
- Interacts with experts in the field to obtain feedback on products and source appropriate faculty to give presentations on behalf of the company
- Proactively acts as a liaison between the commercial group and the clinical development organization
- Participate in and provide Medical support of ENHANZE Success Team (EST) and all active partner Core Teams (current and future)
- Understand, interpret and explain scientific research and literature
- Exceptional scientific written and verbal communication capabilities and skilled at a high level of influencing with diplomacy and capable of effectively combining science and relationship building
9
Experience For Medical Director, Global Medical Affairs Resume
- Considerable organizational awareness (e.g., inter-relationship of departments, business priorities) including experience working in a cross-functional or matrix environment and in partnership with other companies
- Provide solid medical leadership throughout the organization where needed
- Demonstrated fluency in the fundamental underpinnings of cancer biology, therapeutic and supportive care medicines, clinical trial design and execution
- Proven ability to understand, interpret and explain scientific research and literature
- Proficient at building and nurturing working relations throughout the organization and with business partners to achieve business goals
10
Experience For Director, Global Medical Affairs, Immuno Resume
- Knowledge of government/industry guidelines and U.S. healthcare landscape (managed markets, emergence of evidence based medicine, current regulatory environment, etc.) for appropriate scientific & medical exchanges and communication with customers
- Assist in the development of department or cross-functional SOPs and policies
- Understanding of government/industry guidelines and U.S. healthcare landscape (managed markets, emergence of evidence based medicine, current regulatory environment, etc.) including, but not limited to, the Sunshine Act
- Effectively and diplomatically present ideas and document complex medical/clinical concepts
- Provides Medical Affairs input into overall Business plans
- Lead the ViiV Medical Affairs organization to ensure clear direction is provided to both Medical and Commercial colleagues on the Medical Affairs strategy
List of Typical Skills For a Global Medical Affairs Resume
1
Skills For Senior Global Medical Affairs Leader Resume
- Strong experience developing and managing strategic relationships with medical experts/opinion leaders and proven business understanding is strongly desired
- Excellent data interpretation and presentation skills,
- Excellent interpersonal, analytical, communication (written as well as oral), in addition to results oriented project management skills
- Program management with demonstrated experience managing multiple large projects concurrently
- Highly innovative with the ability to drive a complex and changing environment and effectively manage/resolve issues within the TA is required
- Prior experience in Immunology/Immuno inflammation, dermatology Medical affairs Life Cycle management
- Proven Global Medical Affairs leadership experience in LOC and above country roles
- Demonstrable cross functional matrix leadership skills
- Extensive management experience and experience building Medical Affairs teams
2
Skills For Global Medical Affairs Leader Resume
- Demonstrated ability to motivate, mentor, manage and provide clear, unambiguous expectations and priorities for the teams
- In a matrix environment, able to effectively collaborate with and influence partners across divisions
- Medical affairs leadership or clinical development experience with proven track record of contribution to medical or clinical development strategies
- Experience in conducting and interpreting clinical studies is required
- Experience in developing and delivering presentations and publications in English
- Experience in leading and participating in cross-functional teams
- Demonstrated track record in delivering new initiatives, capabilities and leading impactful medical initiatives desired
- Demonstrated success in building and executing multi-year strategic roadmaps desired
3
Skills For Head of Global Medical Affairs Resume
- Experience leading teams with a track record of delivering results in a complex environment desired
- Strong working relationships with Global leaders in Respiratory medicine, including KEEs, professional societies, pharmaceutical companies desired
- Strong stance on compliance and awareness of local, regional and global regulations relating to the development and launch of Pharmaceutical products
- Experience in Global Medical Affairs or similar function and working cross-functionally across a product team
- Maintain the care and security of materials and equipment and actively participating in effective communication practices
- Co-operate as far as need to enable Varian to comply with regulations involving health, safety and welfare
- Clear experience managing multiple high-level projects at various stages of development
- Partner with the GMAL in developing global medical affairs strategy and plan for the compound based on prioritized regional needs
- Lifesciences industry or other relevant commercial experience is advantageous
4
Skills For Global Medical Affairs Director Resume
- Develop strong cross-functional relationships at Illumina to ensure Medical Affairs strategy and personnel align with key corporate objectives
- Solid understanding of the drug development process over different stages
- A solid understanding of clinical study design, data analysis and interpretation as well as the principles of observational studies and health economics
- The Medical Evidence Outcomes Research (MEOR)
- Experience in medical affairs organization
- Experience in the Pharmaceutical or biotechnology industry
- Proven ability to identify and resolve complex problems
5
Skills For Global Medical Affairs Associate Resume
- A strong global and strategic mindset
- Experience with Pre-Launch activities
- MD with experience in respiratory therapy area (preferably allergy / pulmonary medicine space)
- Clinical Development experience desirable, but not essential
- Experience in Medical Affairs
- MD, MD PhD, or PhD with clinical experience in oncology, reproductive health, or human genetics in industry
- Understanding of resourcing and budgeting
6
Skills For Director, Global Medical Affairs, Lymphoma Resume
- Heading up the Global Steering Committee and related subgroups. Drives subgroup meetings and GSC deliverables
- Acting as the Medical reference contact for ViiV Local Operating Companies and ViiV regional offices
- Understanding of cardio-renal therapeutic area, commercialization strategy, regulatory issues, and the pharmaceutical industry in general
- Being an ambassador and influencer for HIV in general through network with external experts, health officials, policy makers and clinicians
- Taking reasonable care for the health and safety of all staff at Varian
- Actively engage, support and guide all participating AstraZeneca Marketing Companies, ensuring global alignment with objectives
- Provide medical support to GMSA in developing publication strategy, reviewing and editing publications, posters, and presentations
- As a member of the executive management team assist in formulating the company’s future direction and supporting tactical initiatives
- Appetite for exploring new ideas and innovating!
7
Skills For Executive Director, Global Medical Affairs Resume
- Act as the functional lead for global Medical Affairs at Illumina and championing excellence in strategy, innovation, and execution
- Strategic thinker with ability to understand emerging medical affairs trends and implications from a business standpoint
- Fluid use of SharePoint and web conferencing tools
- Ensure that all promotional and marketing materials meet Varian standards of scientific and technical accuracy and integrity
- Travel required, comprising approximately 20-30%
8
Skills For VP, Global Medical Affairs Resume
- Plan and coordinate the design, conduct, analysis, reporting and publication of Oncology Global Medical Affairs Studies
- Provide strategic review of Oncology Investigator Initiated Research (IIR) and Post Marketing Commitment (PMC) studies
- Establish and Lead Medical Launch Team (MLT) or Medical Steering Team (MST) for the assigned asset(s)
- Build and lead the Global Medical Affairs organization, setting the strategic direction of all Medical Affairs functions across the Amicus organization
- Develop plans and budgets to support the global marketing function
- Oversee employee relations, employee development and training
- Be a coach and mentor who inspires the team and organization toward excellence, providing support, challenges and professional growth for the senior team
9
Skills For Medical Director, Global Medical Affairs Resume
- Drive ideas/concepts for constructing the product pipeline - e.g. new products, OTC switch candidates, new combinations, new technologies)
- Accountable for the execution of phase IIIb and IV studies, including post-approval commitments, if applicable
- Lead and implement global scientific engagement program including development and maintenance of Scientific Platform and ensure medical governance
- Responsible for contributing to the development, implementation and execution of the strategy for Medical Affairs globally
- Communicate existing and potential paradigm shifts in relevant cancer treatments and key competitors to guide future development strategies
10
Skills For Director, Global Medical Affairs, Immuno Resume
- Provide medical input and support in developing clinical, scientific, and future commercial strategies
- Product knowledge-understand the medical and therapeutic usage of Takeda’s products
- MBBS, MD or equivalent medical qualification is mandatory
- Build and manage a global Medical Affairs team to support Illumina’s product development, test adoption, and reimbursement
- Develop and evolve a global Medical Affairs strategy
List of Typical Responsibilities For a Global Medical Affairs Resume
1
Responsibilities For Senior Global Medical Affairs Leader Resume
- Lead the development and capability building of the Medical Affairs organization, to enable it to be ‘industry leading’ at both in-country and leadership levels, to ensure the organization is fit for purpose to respond to the challenges of 2DR
- Oversee operational aspects of Medical Affairs, Governance and Patient Affairs within VHC, including Scientific Engagement and medical aspects of Commercial Practices
- Provide strategic medical input into strategic plans. Medical SWOT analysis of ViiV HIV Vaccines and the local competitive environment. Supporting the Regional Medical Directors on any medical issues beyond the scope of competences of the local or regional offices
- Drives global processes for promoting effective evidence generation strategies
- Experience from Medical and Scientific Affairs and/or clinical experience in the therapeutic areas assigned for more than 8 to 10 years
- A demonstrated track record leading highly matrixed, cross/multi-functional work teams comprised of high-level managers and executives is required
- Sculpt the publication plan, review and contribute to the writing of publications
- Medical Support and leadership (for crisis management)
- Support and execute on the Global Medical Affairs strategy and Life cycle plan for Dupilumab pediatric indication for Atopic Dermatitis
2
Responsibilities For Global Medical Affairs Leader Resume
- Support the execute on life cycle management plan for the pediatric indication of Dupilumab
- Provide content support for Scientific Communication activities (scientific platform slide decks etc..)
- Provide relevant support to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials. Provide medical content for payers need for Atopic Dermatitis in adults and pediatrics
- Organize and Lead advisory boards or roundtables for the Pediatric indication of Dupilumab in Atopic Dermatitis and gain strategic insights for medical, scientific, and development strategy
- Ensure a patient-centric approach to development of medical activities under his supervision
- Collaborate with the Alliance to execute the activities under his responsibility in alignment with the Brand plan and Global Medical Affairs Plan
- Interacting with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in Oncology. Also, maintaining external orientation by participating actively in external Oncology events and activities
3
Responsibilities For Head of Global Medical Affairs Resume
- Support the bone Global Medical Affairs Team
- Support the development and execution of global medical external stakeholder engagement strategy to strengthen external understanding of the unmet need and medical value of the products for appropriate patients via opinion leaders, advocacy groups, patient groups, professional societies, and payers
- Support the development and execution of global medical communication and evidence generation strategy to support the value proposition of Amgen’s products and maximize access and reimbursement
- Support the development and execution of a global medical communication strategy including clinical narrative framework, scientific platform, core content, medical education, and advisory boards
- Support the continued build-up of Amgen’s reputation as a reliable science-based and patient focused partner
- Develop global medical affairs strategy and plan for the compound based on prioritized regional needs. In addition, partner closely with the Vice President of Global Medical Affairs, Myeloma Strategy Leader and other GMALs to ensure one franchise strategy
- Work with the CDTs to ensure integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing medical affairs global and regional value needs
4
Responsibilities For Global Medical Affairs Director Resume
- Collaborate closely with the regional medical affairs representatives to develop integrated global medical affairs strategies and plans and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions
- Synchronize input and output of the Med Affairs plan with the strategic and business plan calendars
- Lead global publications planning process oversight (with vendor support) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development
- Review of manuscripts to ensure alignment with strategy and effective communication/presentation in internal and external audiences (e.g. Symposia)
- Responsible for review and approval of proposed evidence generation activities within Medical Affairs for oncology products. Responsible to ensure all global activities follow J&J Compliance principles, e.g. Health Care Compliance, etc
- Excellent knowledge of study execution, benefit risk management and lifecycle management is required
5
Responsibilities For Global Medical Affairs Associate Resume
- Good scientific knowledge, ability to hold peer-to-peer discussions with key external partners is required
- Delineate the Medical Strategy for Oncology pipeline asset(s) that complements the Development Strategy
- Ensure all regional studies are consistent with agreed Global Medical Strategy
- Provide Medical expertise and insight on development and commercial issues through membership of the Global Project Teams (GPTs) and Brand Launch Teams (BLTs) or Global Brand Teams (GBTs)
- Plan and conduct Scientific Advisory Boards with Thought Leaders (TLs) and External Customers
- Represent Bayer’s viewpoint on product to Thought Leaders, Scientific Advisors, Health Authorities and to other External Stakeholders
- Provide Medical Affairs input to Global Clinical Development Programs
6
Responsibilities For Director, Global Medical Affairs, Lymphoma Resume
- Provide Medical Affairs input in the determination of probability of success and feasibility
- Provide Medical Review of promotional material from the GBT for global use (e.g. Product Monographs, Brochures, Press Releases, Q&A’s, and Field Communications)
- Lead Medical Affairs activity connected to the Medical Affairs (MA) Scientific Publication Process, Global Thought Leader Development Programs and Global Medical Congress Activity
- Provide Medical Affairs input into core labeling and pharmacovigilance documents for marketed products (e.g. risk management plans and benefit analysis for risk-benefit assessments) and actively contribute to label development and label negotiation process (with Health Authorities)
- Establish and Lead Medical Affairs Matrix team for Global Brand in Oncology
- Ensure and oversee the development of clear and well communicated medical strategies for each Amicus product that can be used to guide development of robust Medical Plans that meet the needs of local markets
- Represent and manage Amicus clinical programs in working with the Regulatory and Reimbursement agencies. Build partnerships and relationships with the scientific and medical community. Represent Amicus externally in scientific presentations, conferences and industry groups
7
Responsibilities For Executive Director, Global Medical Affairs Resume
- Oversee the interpretation, publication/public disclosure, and accurate use of scientific data concerning migalastat in Fabry disease and ATB200 in Pompe disease (as well as future products), and oversee the development of scientific content for medical communication and scientific education initiatives
- Oversee the planning, development, execution and reporting of all Phase 4 post-marketing research. Ensure there is robust governance and that all Phase 4 research is conducted in a compliant way and to the highest ethical standards and scientific rigor
- Form and enhance working relationships with key external research collaborative groups
- Provide strategic input into the development of Phase 3b & 4 studies in collaboration with other stakeholders
- Chair the Global IIP Review Committee
- Interact with key members of the medical community to assist in understanding current practice issues for Fabry and Pompe disease, including developing and maintaining effective and optimal relationships with Key Opinion Leaders
- Actively participate and ensure Medical Affairs contributions to various teams and taskforces to build and support the Amicus portfolio in all facets of the business, with an emphasis on
- Interacts with experts in the field to obtain feedback on products
- Provides support and expertise to global medical affairs teams
8
Responsibilities For VP, Global Medical Affairs Resume
- Prudently manage resources within jointly established budget guidelines
- Keep accurate records and provide timely and accurate reports related to programs and services
- Participate in and contribute to professional development programs
- Implement and model high standards of work performance
- Observe and Comply with all Varian Corporate Policies
9
Responsibilities For Medical Director, Global Medical Affairs Resume
- Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements
- Ensure NHSc leadership in the scientific community by liaising and partnering with external stakeholders (e.g. KOLs, Experts, Scientific Associations and Patient Associations) and sharing within NHSc relevant insights gathered to inform development and commercialization
- Provide recommendation on PhIV studies
- Inform commercial strategy throughout product lifecycle
- Provides Governance across Medical Affairs to maximize and measure the value of activities across the company including oversight and alignment of BSC's medical-related strategies, policies, practices and the impact of medical strategies and initiatives on overall product quality and cost-effectiveness of care
- Works closely with Clinical, Medical Affairs and cross functional teams including R&D, marketing, reimbursement/market access, regulatory, and all the regions to enhance collaboration and effectiveness of interactions, including unifying the medical voice for BSC
- Establishes and develops relationships with a wide variety of physicians, at a peer-to-peer level, to achieve scientific, educational and patient outcome goals on behalf of BSC
- Create a data driven strategy that evaluates impact and effectiveness of clinical investments, performance and strategies and advances the company’s clinical capabilities through use of predictive data and analytics
10
Responsibilities For Director, Global Medical Affairs, Immuno Resume
- Develops Global Medical Affairs Center of Excellence to continuously improve business effectiveness, simplification and sharing of best practices across the businesss and regions
- Creates an environment encouraging innovative thinking and risk taking within scope of business responsibility
- Promotes and manages change to enhance Medical Affairs organizational capabilities
- Mentors and develops medical affairs employees across the business and regions
- Develops and manages a budget for the Medical Affairs COE
- Works closely with legal and regulatory to stay abreast of HCP compliance rules and ensuring that all meidcal affairs activities and services are fully compliant
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