Director, Medical Affairs Resume Sample
Estevan Ritchie
219 Greenholt Villages,
Phoenix,
AZ
+1 (555) 748 1704
Work Experience
Director, Medical Affairs
06/2017
-
PRESENT
Houston, TX
- Excellent verbal & written and communication skills
- Experience writing and editing scientific publications
- Current knowledge of compliance guidelines and regulatory requirements that impact Medical Affairs activities
- Experience in working cross-functionally with internal colleagues, particularly in HEOR, Commercial, Safety and Regulatory
- Demonstrated ability in project management, objective setting, meeting management and plan execution
- Work on multiple projects simultaneously and effectively prioritize workload
- Role model for others in line with Gilead's Core Values
- Develop and maintain relationships with international thought leaders through Advisory Boards, Professional Associations and Meetings to achieve company’s scientific objectives
- MD, PharmD or PhD with 12 years relevant experience of which eight years are in pharmaceutical/biotech industry in medical affairs or clinical development, with strong medical focus and experience in regards to medical plans, publications, medical information, education grants, investigator initiated studies, and Phase IIIb/IV programs, or equivalent academic or clinical experience
Associate Director, Medical Affairs
01/2014
-
05/2017
Philadelphia, PA
- Coordinate and provide in depth scientific and technical input to migraine 4 study designs and publications
- Maintain an in depth understanding of the relevant science and provide regular scientific updates to internal customers. Ensure in depth understanding of current and future Allergan products in migraine
- Collaborate with marketing, medical, legal and regulatory by providing in depth scientific and technical input to therapeutically aligned marketing campaign concepts and support creation and delivery of scientific training materials
- Work with the Sci Comms team to develop therapeutically aligned scientific slide decks and other support materials for US MSL team
- Participate in ClinCom process for evaluation of investigator driven studies requests
- Provide input into product development plans, in particular the clinical research program and design of clinical development plan (in collaboration with R&D)
- Lead Medical Director Team
- Lead scientific and medical input to clinical and regulatory documentation (Investigator’s Brochures, trial protocols & reports) and ensures adequate medical content and clinical interpretation of clinical documents to be submitted as part of registration in collaboration with Regulatory and other R&D functions
- Lead the cross functional medical governance team
Associate Director Medical Affairs
11/2009
-
11/2013
Dallas, TX
- Liaise with cross-functional leadership to develop and execute a medical plan aligned with data and education needs of Avanir products and the diseases they address
- Provide scientific/clinical input to commercial teams supporting their strategic and tactical decisions
- Responsibilities for safety evaluation, medical monitoring, and expertise oversight in clinical trials/ programs
- Work closely with clinical on data analysis to maintain timelines in developing publication and communication plan
- Serve as the medical expert supporting execution of the publication plan, including manuscript development, review and quality assurance of the publication with the author team
- Accountable for medical affairs communication pieces and ensuring that disease state, product, and pipeline presentations are scientifically accurate, complete, up-to-date, and aligned to the communication platform
- Assure external presentations are consistent with company standards
Education
University of North Carolina at Asheville
2003 - 2008
Science's Degree in Business
Professional Skills
- Work seamlessly with a wide range of cross-functional partners (eg. platforms, commercial organization, regulatory, safety, quality) to drive innovation, provide support for marketed products and manage issues
- Strong communication skills, medical writing experience, well developed communication skills, including the presentation of scientific/technical information
- Good interpersonal and influencing skills and good/written communication and presentation skills
- Strong leadership experience and written/verbal communication skills
- Proven leader with passion and skills for strategic and critical thinking, problem solving, motivating and mentoring team members
- Prior experience working in a matrix organization as well as cross-functional collaboration with commercial/marketing departments strongly desired
- Evidence of strong scientific writing skills and analytical thinking are required
How to write Director, Medical Affairs Resume
Director, Medical Affairs role is responsible for presentation, interpersonal, leadership, scientific, medical, organization, negotiation, analytical, building, clinical.
To write great resume for director, medical affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director, Medical Affairs Resume
The section contact information is important in your director, 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 Director, Medical Affairs Resume
The section work experience is an essential part of your director, 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 director, 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 director, medical affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director, Medical Affairs resume experience can include:
- Innovative, flexible, self-starter with ability to multi-task, prioritize and work independently. Excellent planning and organizational skills
- Excellent Computer skills required, specifically Windows software, including Word, Excel and PowerPoint
- Strong people management and leadership skills, leading a matrixed/cross functional team is required
- Excellent problem-solving skills and judgment and ability to anticipates and proactively address issues
- Strong interpersonal and matrix management skills for coordination and interaction with multiple teams, cross-functionally and across therapeutic areas
- Good interpersonal, communication, negotiation, presentation and networking skills
Education on a Director, Medical Affairs Resume
Make sure to make education a priority on your director, 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 director, 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 Director, Medical Affairs Resume
When listing skills on your director, 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 director, medical affairs skills:
- Proven ability to think strategically and have strong analytical skills
- Excellent relationships with KOLs, strong network building skills
- Effectively interacts with and collaborates at all levels in the organization, including effective interface at the senior management level
- Able to effectively handle multiple tasks and priorities in a fast-paced environment
- Strong interpersonal skills and ability to work with others in a positive, collaborative manner
- Excellent communication and organization skills paired with high professional presence and credibility
List of Typical Experience For a Director, Medical Affairs Resume
1
Experience For Associate Director, Medical Affairs Resume
- Excellent capability to build relationships with KOLs, strong network building skills
- + Excellent Computer skills required, specifically Windows software, including Word, Excel and PowerPoint
- Strength in communicating effectively (oral and written) with both scientific and lay audiences,
- Service oriented, problem solving mindset, able to deal with multiple priorities, excellent project management
- Motivate and provide leadership in a growing enterprise; experience building, manage performance coaching, and leading teams
2
Experience For Senior Director, Medical Affairs Resume
- Promote effective communication between internal and external groups regarding Medical Affairs initiatives
- Proven ability to develop cross-functional corporate strategy, and the ability to set the working culture of the Medical Affairs organization
- Previous experience managing direct reports is required
- Demonstrated ability to manage complexity and competing job demands
- Experience working in a matrix organization with cross-functional teams is required
- Partner with Head of HEOR to develop data and evidence needs in support of Avanir products
3
Experience For Associate Director Medical Affairs Resume
- Relevant academic, clinical and industry experience
- Rare Disease experience highly desirable
- Address medical and scientific issues and to ensure the appropriate use of all Janssen marketed products for Solid Tumor Oncology
- Provide clinical analysis and support for Janssen products for Solid Tumor Oncology
- Defining the country Medical resource needs and leading the Medical budget planning, resource allocation and budget management
- Driving the international medical strategy associated with our emerging 6 Star GI programs
- Leading NAMA activities for immuno-oncology with focus on PD-1 inhibition
4
Experience For Director Medical Affairs Resume
- Lead the Medical Affairs team by recruiting, developing, and retaining top talent by providing management coaching and direction to the MSL team
- Routinely assessing, maximizing and communicating the performance of the medical affairs team
- Assists in writing and amending customer-facing literature such as procedures, package inserts, bulletins, and notices
- Provides budget forecasting for future revenue and expenses and recommends to invest in, divest in, or maintain current funding in all clinical operations
- Provides regular reports to Medical and Scientific Affairs and Marketing regarding proficiency panel performance
- Interact with key external experts to ensure consistent messaging
- Chair HEM/ONC Med Affairs POA meeting
5
Experience For Country Director Medical Affairs UK & Ireland Resume
- Create, develop, and enhance relationships with the medical community; assist Ferring colleagues with physician communications
- Actively participate on advisory boards, at clinical investigator meetings, training events, and regional, national, and international meetings as required
- Support Business Development and due diligence activities for new product licensing and acquisitions
- Support the development of scholarly publications arising from Janssen studies
- Maintain up-to-date scientific expertise with regular attendance at key scientific / clinical / economic conferences, training sessions and preceptorships
6
Experience For Director, Medical Affairs Operations Resume
- Participate in creation and review of publications and other data dissemination, including abstracts, posters and manuscripts
- Support to the HAC Business Unit, Regulatory and Market Access Group to ensure the successful management of existing products and launches of new products
- Provides input, reviews and approves advertising copy/promotional copy, public statements and internal statements from a local (US) Medical perspective
- Serve as the CMO Lead for assigned Core teams involving products within the TA
- Co-Chair brand team with Marketing brand lead
- Implement DVP’s vision for on-market Product Performance, Medical Education and Training, and Medical Information
7
Experience For Exec Director, Medical Affairs Resume
- Participates in the assessment and procedures of adverse event reporting as needed
- Provide medical support and direction to the Laboratory Operations leaders, acting as first point of contact for Central Labs
- Ascertain the medical accuracy and fair balance of medical information in promotional and medical materials
- Provide clinical/scientific education for internal stakeholders
- Provide medical input into the safety profile in collaboration with safety and regulatory
- Attend and represent Avanir at regional and national medical conferences to support medical tactics and enhance Avanir awareness and presence
- Ensure the development and maintenance of relationships and co-operation with regulatory authorities and other appropriate external bodies. Maintain scientific peer relationships with external experts and institutions of excellence
- Representing GI International Medical Affairs on cross functional global teams
- Accountable for review of IIS and grant proposals; QC data as needed
8
Experience For Director Medical Affairs Operations Resume
- Establishing patient-centric relationships with international GI Thought Leaders through partnering on our innovative GI programs including: Non-Alcoholic Steatohepatitis (NASH), Diabetic Gastroparesis, Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD)
- Work with Global Medical Team leader on in-year implementation of global medical strategy
- Medical review of promotional material to ensure adherence to the company’s high ethical standards and relevant Codes of Practice
- Willingness to travel approx. 30-40% of the time both nationally and internationally
- Write Gilead Medical Affairs Plan (GMAP) for Hematology/Oncology
- Write Plan of Action (PoA) for HEM/ONC Medical Affairs organization
- Review Medical Science Plan of Action
9
Experience For Senior Director Medical Affairs Resume
- Develop strategic topics for MS trainings
- Review IMED strategy plan and needs assessment
- Review and give medical perspective to IMED needs assessment
- Serve on Independent Med Ed Committee (selection committee)
- Present scientific data at internal and external Meetings involving Medical Affairs (eg, including at MA Advisory Panels and Investigator Meetings and professional associations)
- Develop comprehensive knowledge of disease state and product data. Use this knowledge to serve as product and disease state expert for the development of Medical Affairs, Commercial and Corporate materials, Advisory Board presentations, Health Outcomes needs, Clinical Study designs, publication plan, MSL strategy, etc..
- Build and continuously develop an in country medical team in a highly, matrix environment that
- Develops and continuously maintains the highest scientific and medical expertise with all relevant diseases and products and is acknowledged both internally and externally as such
- Demonstrate the appropriate leadership, direction and accountability for
10
Experience For Executive Director, Medical Affairs Resume
- Ensuring field-based medical teams have clear objectives, performance metrics and agreed working relationships with other functions
- Creating development opportunities for team members through implementation of development plans, training opportunities and relevant opportunities
- Develops external relationships with relevant medical groups (e.g. research centers, hospitals, professional associations) in support of Alexion objectives
- Leads all activities in accordance with the latest, relevant current local and regional pharmaceutical regulations and Alexion policies and procedures
- Leading and managing direct reports to ensure achievement of objectives, personal development, and ensuring the team is trained and equipped to achieve established goals
- Organizing the country pharmacovigilance activities, in conjunction with Regional and Global pharmacovigilance, including assigning Alexion Drug Safety Officer responsibilities to ensure pharmacovigilance requirements are fulfilled according to regulatory and company policy
- Organizing the country medical information function, ensure timely response to medical information inquiries and collation of requests, utilizing global medical information resources and in line with local regulatory requirements and company policy
List of Typical Skills For a Director, Medical Affairs Resume
1
Skills For Associate Director, Medical Affairs Resume
- MD, PharmD, or PhD with demonstrated ability to effectively lead and coach scientific / medical colleagues at all skill and knowledge levels
- Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy
- Prior experience in Clinical Trials Management and good knowledge of GCP ( desirable)
- Working knowledge of compliance-related topics relative to clinical diagnostics either through prior experience or formal training
- Planning, organizational, project management and analytical skills
2
Skills For Senior Director, Medical Affairs Resume
- Strong management experience directing staff and managing budgets
- Strong leadership capabilities, a strong work ethic, and the ability to keep pace with the organization's growing and changing needs
- GMC registered Physician or GPhC registered Pharmacist with proven pharmaceutical / biotechnology industry experience
- GMC registered Physician with proven pharmaceutical / biotechnology industry experience
- Laboratory management experience and demonstrated financial awareness
- A thorough knowledge of scientific information, the ability to interpret and assimilate scientific data, and thought leader development skills
- In a matrix environment, able to effectively collaborate with partners across divisions
- Excellent interpersonal, analytical, communication (written as well as oral), in addition to results oriented project management skill
3
Skills For Associate Director Medical Affairs Resume
- Experience reviewing, approving and overseeing post marketing clinical studies
- Strong business acumen including working knowledge of medical care and payer landscape
- MD, PhD or PharmD is required; recognized expertise through 5+ yrs clinical and/or research experience (including publications) in therapy area is desired
- Flexibility to manage multiple initiatives in response to continuously and rapidly changing priorities
- Be a decisive, hands-on team player and building in order to get others to cooperate and develop common goals
4
Skills For Director Medical Affairs Resume
- Experienced in delivering presentations on clinical topics to global KOLs and hospital/medical/clinical laboratory staff
- Experienced working in a multi-cultural environment and in a matrix structure
- Strategic acumen: Excellent understanding of strategic needs of the affiliate organization
- Specialty training and/or experience in Oncology
- Experience in leading international teams and peer leadership interaction
- Specialty training and/or clinical experience in cardiology
- Experience working with field-based colleagues/MSLs
- Experience in Haematology and / or Oncology
- Final Medical Signatory experience required
5
Skills For Country Director Medical Affairs UK & Ireland Resume
- Significant line management experience
- Identify, prioritize and manage appropriate resources to successfully achieve strategic medical affairs objectives
- Experience in educational event design- and planning
- Experience in the pharmaceutical industry
- Established long term relationships with identified KOL’s with proven ability to achieve scientific, educational and business goals
- Possesses knowledge of the operations, structure, and effective leadership of a large group of specialized clinicians
- Previous Experience with Medical Affairs
6
Skills For Director, Medical Affairs Operations Resume
- Experience with MSL Management
- Proven ability to interact with external customers (Medical Community and Payers)
- Proven ability to present scientific data and key messages to academic and non-academic audience
- Experience in the biotech/ pharmaceutical industry and/or clinical practice/academic setting in the field of hematology/oncology
- Experience that satisfies the personnel requirement of CLIA 1988 or other applicable regulations for laboratory director
- Experience in hematology/oncology with a recent focus on myeloma
- Organizational agility and ability to cultivate strong internal/external network
- Strong operational and project/ timeline management capabilities
- Focused and quality minded – Logical, strategic thinker and effective problem solver
7
Skills For Exec Director, Medical Affairs Resume
- Three (3) or more years of experience in country / region Medical Affairs
- Three (3 )or more years of experience in country / region Medical Affairs
- Willingness to travel; possesses valid driver’s license
- Demonstrated track history of KOL development and management and organization of advisory boards
- Conducting and overseeing training and education events for internal and external stakeholders
- Learning agile and ‘scalable’ to take on increasing responsibility and management as Amicus grows
- Understanding of pharmaceutical business, drug development and regulatory process
- Collecting insights from all healthcare stakeholders, such as KOLs, nurses, competent authorities
- Develop and manage budgets for medical activities and provide input into the affiliate budgeting and planning process
8
Skills For Director Medical Affairs Operations Resume
- Eight (8) to ten (10) years in medical staff administration and credentialing preferably at a university affiliated teaching hospital
- Assist the CMTO with organizing and conducting topical Scientific Advisory Board Meetings
- Collaborate closely with the local Country Clinical Lead on any issues relating to site selection and communication for MS programmes
- Facilitate sharing of best practices and knowledge across products and locations
- Evaluate complex human use data including results of clinical trials
- Collaborate in developing responses to Health Authority queries and requests for information
- Interpret and keen understanding of accreditation/regulatory environment
- CPCS - Certified Provider Credentialing Specialist National Association Medical Staff Services
- Creative problem solver, with the ability to offer innovative, consensus-building solutions
9
Skills For Senior Director Medical Affairs Resume
- Possess an active Indiana state medical license or be qualified and willing to obtain
- Expert knowledge of clinical laboratory systems (testing, operations, finances, and information)
- Basic understanding of relevant guidelines and regulatory requirements
- Collaborate with internal colleagues in sales, marketing and managed care accounts
- Knowledge and understanding of disease area, local health care system / market dynamics, regulations, policies and SOPs, health economic techniques and trends
- Lead design of training and development programs for the RMD teams and Medical Affairs as appropriate
- Identifies resources ensuring highest level of clinical and business competencies of RMDs in support of RMD organizational and business unit goals
- As a member of the Global Med-Clin leadership team provides medical and organizational leadership globally
10
Skills For Executive Director, Medical Affairs Resume
- To develop the AP Medical Strategy for Immunology/Dermatology in line with Global TA/Disease Area Stronghold and Regional Cross-Functional Therapeutic Area Team(s) (RCFT) strategies, taking into account both weighted needs of the AP countries and feedback from the external scientific communities/thought leaders
- To drive the implementation of the AP Immunology/Dermatology Medical Affairs Plan by the Medical Directors/Advisors, Medical Education Specialists and Coordinators, on time and within budget
- To support the Immunology Therapautic Area Lead as required in leading the AP Integrated Value Team (AP IVT) to develop and drive regional TA strategy, ensuring effective communications between the key regional and global groups
- To support and guide New Business Development activities regarding opportunities for Licensing and acquisition in the Franchise , as delegated by the TA Lead
- To represent AP MAF for the Dermatology Global level (GMAT, CDT ad hoc), on strategic and tactical matters, as delegated by the Immunology TA Lead
- Post-graduate qualification such as MRCP, MRCGP, and/or Diploma in Pharmaceutical Medicine is desirable
- Identified appropriate SLs with input from manager. Develops professional relationships and communicates with assigned SLs to ensure access to medical and scientific information on Merck products and areas of therapeutic interest. Ensures SLs have a medical contact within Merck
- Conduct peer to peer scientific discussions and maintain a reliable presence with those SLs to identify needs/opportunities to improve population health in assigned therapeutic area(s); discusses appropriate evidence that can contribute to healthcare solutions
- Demonstrates and models excellent performance in the medical communications role
List of Typical Responsibilities For a Director, Medical Affairs Resume
1
Responsibilities For Associate Director, Medical Affairs Resume
- Ensuring effective team communication, performance and documentation of medical affairs activities and knowledge through the application of suitable reporting systems and structures
- Identifying training needs with other functional leaders and ensure implementation of training programs for the commercial teams and other functions, providing medical leadership and education in line with local and global strategy and preparing staff to handle interactions with customers
- Collaborating with Clinical Operations to manage the in country Clinical Operations Lead role and ensuring their activities are prioritized to meet the clinical operations and country objectives
- Ensuring the country Medical team in all existing and potential new therapeutic areas are appropriately resourced, directed and integrated with other functions to
- + Excellent capability to build relationships with KOLs, strong network building skills
- Long term experience within Medical Affairs in the pharmaceutical industry or similar relevant experience
- US and International experience in teaching, working, or conducting clinical studies
2
Responsibilities For Senior Director, Medical Affairs Resume
- Experience and knowledge of the drug development and/or commercialization process desired
- + Experience and knowledge of the drug development and/or commercialization process desired
- + Strong identification with Celgene’s values and objectives
- Develop strong relationships with key opinion leaders, key professional societies and organizations, with a special focus on US
- Demonstrated ability to build credible professional relations with Key Opinion Leaders in the fields of Sleep, Psychiatry, and other CNS disciplines
- Developing and implementing Medical Affairs’ initiatives to support the needs of Celgene UK & Ireland
- Interact with key members of the medical community to assist in understanding current practice issues for Fabry disease, including developing and maintaining
- Manages departmental operating budget and ensures spending is within budget guidelines
- Provide strategic medical management of Gastroenterology and Hepatology therapeutic areas including planning and execution
3
Responsibilities For Associate Director Medical Affairs Resume
- Collaborates with operational leaders in creating future budgets for capital and operating expenses included FTE’s
- Drive the identification and development of Key Opinion Leaders, other important customers and stakeholders, including professional organizations
- Provide medical leadership, insight and strategy to all Alexion activities, collaborating across functions, including ensuring the highest level of medical education for all Alexion employees to maximize patient outcomes
- Identify and implement appropriate high-impact medical research projects to support the business objectives, including Alexion–sponsored and investigator initiated projects
- Previous training, development, policies and technical systems experience
4
Responsibilities For Director Medical Affairs Resume
- Knowledge and understanding of clinical and regulatory guidelines, legal and financial compliance, and corporate medical affairs operations
- Conduct medical training of the commercial team in accordance with global strategy and local regulations
- Ensures wRVU productivity goals are being achieved
- Ensures adherence to the current budget for all capital and operating expenses
- Critically review current relevant literature, providing relevance to the therapeutic area and product
- Manage requests for Alexion product supply in compassionate use cases, in accordance with local regulations and policy
- Provide medical input to the development of impactful scientific and medical education messages and materials
5
Responsibilities For Country Director Medical Affairs UK & Ireland Resume
- Support reimbursement applications locally or nationally, ensuring knowledge of processes, development of appropriate medical materials and supportive documents and provision of medical expertise as required
- Lead the implementation of medical practices to assess new indications, the treating community, patient pathways, identifying patients for clinical research and to develop a thorough understanding of the disease area
- Initiate and support high impact medical education activities, such as advisory boards, congress symposia, hospital meetings and speaker development programs
- Perform clinical study feasibility and support effective study implementation and ongoing management of Alexion sponsored trials, including disease Registries, to achieve recruitment and objectives, in conjunction with Regional clinical operations
- Support cross-functional teams to ensure patient-focused activities at all times, including timely responses to specific internal and external requests to discuss specific situations and challenges and provide medical affairs support to all stakeholders
- Provide appropriate and timely medical support, including time spent in the field, to all commercial team efforts, in particular to patient identification, increasing the urgency to treat, access to funding and appropriate product utilization, with the ultimate goal of maximizing patient outcomes
6
Responsibilities For Director, Medical Affairs Operations Resume
- Attend appropriate national and international meetings and congresses to gather intelligence, assist personal education, ensuring to utilize these opportunities to develop relationships with important customers
- Any other needed task under request
- Executes Scientific Leader event planning in their region from the GHH perspective in collaboration with MSD Vaccines’ Global Health & Medical Affairs (GHMA) team and GDSAs from the Research Lab perspective
- Maintains navigational electronic database to document on- and off-label unsolicited requests for information from HCPs in accordance with Haemonetics’ internal guidelines and FDA guidance for industry
- Diagnostic laboratory experience is required
7
Responsibilities For Exec Director, Medical Affairs Resume
- Direct recent experience in a diagnostic laboratory highly desired
- Deep expertise in at least one area of diagnostics for which Cepheid has products, in the areas of general microbiology, and/or virology (molecular)
- Travel up to 40-50% time
- Responsible for alignment with trial leaders, TMTT’s Biometrics, Regulatory Affairs, Global Healthcare Economics and Reimbursement (GEHR), Marketing, Strategy and Quality
- Support Global Medical advisory boards and trainings including development of content and presentation of data
- Provide guidance to the Pharmacovigilance group including medical evaluation of adverse events arising from both clinical research and post market reports/studies, medical review of periodic safety update reports and provide medical advice for signal detection and management activities( where deemed necessary)
- Contribute to internal Safety Management Teams. Provide medical review to Product Risk Management Plans and contribute to the planning and implementation of pharmacovigilance and risk management strategies
- Liaising with Government authorities and build and maintain working relationships with relevant key opinion leaders. Deliver presentations to stakeholder groups and KOLs on CSL Behring products as part of education-provision and influencing key customers and decision makers
8
Responsibilities For Director Medical Affairs Operations Resume
- Reviewing and approving promotional materials in accordance with internal approval process and MA Code of Conduct, including promotional challenge situations. Reviewing and approving Product Information and CMI documents as required by internal regulatory sign off process
- In addition to the role summary -Provide ongoing assessment of team members’ competencies, develop and implement individualized employee development plans, complete performance evaluations based on observation, deliverables, and feedback from peers and customers
- Provide guidance to the MATL to support the safe, effective, and knowledgeable use of Company products
- Capable of leading and coaching subordinates in research strategies and design of scientific projects
- Optimize therapeutic support of IAM accounts by ensuring collaboration with the Health Systems Medical Affairs team
- Conduct regular performance reviews and ensure personal and professional growth of the direct reports to ensure a clear succession planning is in place
- Within the defined Areas of Interest, is responsible for establishing the strategic needs assessment at the Canadian level in response to regulatory, reimbursement and market conditions. Interacts with Regional Directors of Medical Affairs (RDMA, GMD, GDSA) advocating for support of Canadian initiatives at the Regional/Global level
- Directs and coordinates the activities of the Nordic Regional Medical Liaisons
- Set clear strategic goals for the Regional Medical Liaisons
9
Responsibilities For Senior Director Medical Affairs Resume
- Acts as an integrated member of the Nordic Medical Management Team
- Jointly with the MADL, the TA Director MA is responsible for providing region-specific input on Disease Research Questions (DRQs) collecting input from the affiliates and through consultation with the G3M Team. He/she is responsible to support the MADL in review of investigator initiated trial proposals (IITs) for the disease area
- Through short assignments or ad-hoc secondment opportunities, the TA Director Medical Affairs can cover roles and responsibilities beyond the EMEA region including positions and roles at the global level, substantially contributing to the advancement of globally-led key projects and priorities and co-leading specific projects
- Establish and maintain respectful, productive, and active affiliations within medical/scientific societies and academic teaching facilities for the Women's Health therapeutic area
- Provide Women's Health related scientific input to internal stakeholders across multiple functional areas including Marketing and Sales, Health Economics, Medical Information, and the Medical Science Liaisons
10
Responsibilities For Executive Director, Medical Affairs Resume
- Experience in product planning and development involving publication strategies, product monographs, promotional materials, and/or drug safety surveillance
- Contributions to peer-reviewed publications demonstrating the ability to organize, analyze, and interpret clinical/non-clinical data
- Develop and understand medical/scientific data and translate it into clear and concise teaching programs and presentations
- Commitment to provide leadership by example consistent with Ferring leadership principles
- Provide clinical leadership with scientific and clinical advice
- Present healthcare professionals and decision makers with accurate, unbiased, balanced and timely answers to unsolicited requests for information about Ferring products
- Establish and maintain respectful, productive, and active affiliations within medical/scientific societies and academic teaching facilities for the Urology therapeutic area
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