Director Medical Resume Sample
Allene Renner
801 Lisandro Center,
Chicago,
IL
+1 (555) 753 6299
Work Experience
Group Medical Director
04/2018
-
PRESENT
Dallas, TX
- Continuously evaluate the department’s scope of services to ensure the department is maximizing both its collective talent and the value it brings to the organization; make adjustments accordingly
- Works collaboratively with KPSAHS staff to maximize Imaging/Therapy program in conjunction with other allied health programs
- Conducts on-going program assessment and develops plans to improve didactic and clinical education programs
- Prepares, analyzes, and reports Imaging/Therapy program outcomes, statistical data and surveys
- Works collaboratively with KPSAHS Administration to develop and implement business plans
- Participates in budget planning, including providing input in the capital equipment and budgetary process
- Supervises, mentors, and motivates Imaging/Therapy Program faculty and students to achieve high quality results
- Provides leadership, guidance and resource development to consultants, faculty, advisors and students
Global Medical Director
08/2011
-
01/2018
Chicago, IL
- Oversees selection, performance management, staff development, and retention of Imaging/Therapy Program faculty and students
- Maintains current knowledge of the professional discipline and educational methodologies through continuing professional development and pursuit of scholarly activities
- Travels to clinical/didactic sites throughout Northern California Region to conduct clinical instructions
- Reports directly to the KPSAHS Administration
- Design, develop and implement Medical Country Strategic Plans in alignment with Company Objectives, with reference to global and regional strategic direction as well as the intelligence collected from relevant external stakeholders
- Develop and maintain a scientific network with key thought leaders, advisors and the local scientific community to obtain key insights and to develop strategic partnerships
- Participate in the overall country strategic and annual business planning and resource allocation process
- Be responsible for monitoring medical spending and project costs
Director, Medical Group Operations
01/2007
-
03/2011
San Francisco, CA
- Willingness to travel to both internal and external meetings, including overnight trips. National and international travel is required
- Coordinates all U.S. medical plan vendor interaction and activity, continually looking for cost-out opportunities. Leads US vendor integration efforts ensuring appropriate metrics, data flows, contracting and PG’s are in place control health care spend
- Fill role of medical expert for Transplant within commercial development and commercial operations. Provide medical/scientific assessments of product opportunities in collaboration with R&D. Support training of staff of key countries as appropriate
- Provide Due Diligence support for any possible/proposed merger & acquisition opportunities
- Participate in the Transplant Medicine TAST (Therapeutic Area Strategy Team) and the TAST Pre-Clinical Sub-Team
- Assists in the design and maintenance of the department's database, ensures that it provides accurate and timely support for payment systems
- Monitors external health care delivery environment and internal utilization trends to assess potential for cost savings and alternate delivery modes
- Represents the department's interest in all outside referral and claim areas
Education
Evangel University
2001 - 2006
Science's Degree in Business
Professional Skills
- Demonstrated results orientation and problem solving skills
- Excellent skills using MS Word, PowerPoint and Electronic –Document-Management systems (EDMS)
- Proven leadership skills in a cross-functional global team environment
- Interpersonal and communication skills to effectively interact with a broad range of external and internal personnel
- Excellent presentation skills via WebEx and conference call
- Demonstrated effective verbal and written English communication skills
- Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
How to write Director Medical Resume
Director Medical role is responsible for leadership, business, interpersonal, clinical, development, presentation, english, analysis, medical, cross-functional.
To write great resume for director medical job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director Medical Resume
The section contact information is important in your director medical 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 Resume
The section work experience is an essential part of your director medical 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 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 position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director Medical resume experience can include:
- Possess excellent oral and written communication skills to establish and maintain close contacts and good communication with internal and external customers
- Demonstrated leadership skills with broad business orientation and excellent awareness of commercial needs
- Excellent organizational and problem-solving skills to work independently, identify problems, and aid in their resolution
- Excellent writing skills coupled with comprehensive knowledge of the drug development process and regulatory guidelines
- Effective management, interpersonal, communication, negotiation, and problem solving skills
- Demonstrated skills in leadership, strategic thinking, people development, analysis and innovation
Education on a Director Medical Resume
Make sure to make education a priority on your director medical 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 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 Resume
When listing skills on your director medical 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 skills:
- Strong clinical skills with prior experience in a primary care setting
- Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
- Strong people skills, business acumen and being politically savvy to meet many competing demands required
- Good interpersonal, verbal communication and influencing skills; can influence without authority
- Has demonstrated ability to interact effectively in a multifunctional team setting
List of Typical Experience For a Director Medical Resume
1
Experience For Group Medical Director Resume
- Effective collaborator possessing the ability to foster strong working relationships and build consensus within multidisciplinary teams
- Prioritize and manage completion of multiple deliverables simultaneously with high quality and professionalism as well as set priorities for team
- Experience working in a matrix organization and building collaborative relationships across a number of research and business functions
- Or more of medical writing experience in the pharmaceutical or biotechnology industry
- Demonstrated success managing medical writers (in-house and contract)
- Proven track record of problem solving and risk management across portfolios
- Clinical knowledge and experience
- Identifying and assisting in recruiting qualified investigators and institutions
2
Experience For Global Medical Director Resume
- Monitoring studies to ensure compliance with protocol and integrity of data, analyzing results and reviewing medical section of regulatory submission
- Formulating clinical development plans that encompasses medical affairs, regulatory, HEOR and commercial inputs
- Willing to take initiative on advance projects and able to identify what is necessary to complete tasks
- Supporting HEOR, Access, and Payer Activities as a Medical Lead
- Manage the hiring, supervising, mentoring, and development of internal medical writing staff as the function expands
3
Experience For Director, Medical Information Resume
- Ensures that the right people are placed in the right jobs and staff are performing according to agreed standards
- Manage overall medical writing timelines and resources across project teams (including internal and external resources)
- Act as a key contributor to or lead for peer review sessions; includes acting as a frequent reviewer in internal review/ decision-making committees
- Ensure that the Medical Writing staff is adequately trained and capable of delivering high quality documents to internal and external clients
- Develop a sense of teamwork and common purpose among the staff, especially among the writers, but extending to the entire Medical Writing group
- Publication planning and strategy
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities
4
Experience For Director, Medical Group Operations Resume
- Leads medical affairs activities, generation and dissemination of data supporting overall product scientific and business strategy
- Works with high quality and efficiency, ensuring that agreed upon timelines for projects are met
- Works with other EPD innovation and development functions, EPD commercial & marketing to establish strategies and research programs
- Broad understanding of Diseases, its treatments as well as development programs
- Author, co-author, and critically edit publications including abstracts, posters, slide presentations, manuscripts, and review articles
- Manage medical writing contracted with independent consultants, CROs, and other communication vendors
- Lead the development of medical writing processes, SOPs, work instructions, and document quality control
- Develop a budget for the medical writing department; and
- Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT; and
5
Experience For Director, Medical Services Resume
- Broad scientific, technical and regulatory understanding of most of the functions involved in the development of a device and a pharmaceutical product
- Develop post-marketing medical strategies and Medical Plans
- Participate in brand, tactical, and launch planning to ensure appropriate medical inputs into commercial strategies
- Predict and plan resource requirements and staffing needs
- Manage and mentor medical information and call center staff
- Thought leader relationship development/management
- Hire, develop and oversee the work of your direct and any indirect reports
6
Experience For Director, Medical Writing Medical Dermatology Resume
- Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate or long-term
- Develop clear roles and responsibilities, learning and development, other resources, tools, and expense budgets for the disease area Medical Affairs function and team
- Act as expert participant and contributor on advisory boards and presenter at other external functions
- Provide expert review of published scientific and clinical literature
- Manage medical programs and tactics across multiple projects. Direct others in developing and executing medical strategies, trials, other studies and investigations, communication, education, health economics and outcomes research and publication activities over a range of products within Breast Cancer/Gynecologic/GI oncology
- Take responsibility for design, execution, and data interpretation of post-marketing clinical trials and other post- marketing medical investigations or studies
- Manages statistical and qualitative information concerning patient outcomes and physician/hospital practice patterns in accordance with health plans’ utilization standards
- Intervenes with government customer, hospital or physician contractors to examine cases to ensure methods for meeting these utilization standards while maintaining precedent for quality of case standards
- Plans and develops improved techniques for patient management and the control of health care costs
7
Experience For Senior Director, Medical Writing Resume
- Partnering with global medical affairs on creation of evidence generations plans for the products and defining the clinical strategic plan for product registration, approval and product adoption
- Driving clinical development plans in collaboration with key stakeholders including regulatory affairs, medical affairs and the business
- Develops and implements policies and procedures that guide and support provision of services and assures staff competency
- Continual assessment and improvement of the department’s performance. Promotes the Quality Management program of the facility, maintaining appropriate quality control programs (where applicable)
- Assures that orientation, in-service training, and continuing education are provided for persons in the department
- Reviews all relevant documents and interacts with functional leader and project manager to develop a thorough understanding of project timelines
- Work with service providers/contractors as needed for delivery of high quality documents, including technical and format QC activities
8
Experience For Medical Director, Pharmacovigilance Resume
- Develops and participates in goals and objectives for assigned area(s) of responsibility
- Interprets clinical and non-clinical data in the preparation of various technical reports
- Serves as primary functional representative on project teams
- Contributes to clinical protocol development
- Participates in the development of protocols, investigator’s brochures, informed consent forms, and other necessary study documents
- Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
- Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource
9
Experience For Cardiovascular Medical Director Resume
- Can address complex problems within discipline/project or across disciplines
- Critically analyze research design, methods, and outcome measures
- Facilitate Enterprise and Domain architectural activities that ensure the future viability, configurability, and positioning of provider-centric products within Optum’s Enterprise or in an external Cloud marketplace
- Leadership for regionally developed health care affordability initiatives and execution of national affordability initiatives
- Drive disciplined fact-based decisions
- Apply end-to-end clinical services process to identify risks or opportunities
10
Experience For Director, Medical Operations Analytics Resume
- Provides strategic inputs to the Company's business strategy, ensuring that drug registration is conducted effectively and marketing strategies are tailored to regional needs and requirements
- Aproves the release of promotional materials and press releases for all BI medical prodcuts, ensuring that these meet company standards and accurately reflect the comapny's image
- Provides inputs into the regional budget for Medico-Marketing activities, as per the company's regional business strategy
- Builds opportunities for direct reports to suggest, participate in and contribute to improvement, innovation and knowledge sharing initiatives
- Coordinates at the Corporate level to ensure enough funds are allocated for clinical operations research from the company's Medical II Budget
- Ensures implementation of the company's medical code of conduct
- Participates in management meetings, providing Medical Department perspective and requirements that impact the company's business operations and strategic decisions
List of Typical Skills For a Director Medical Resume
1
Skills For Group Medical Director Resume
- Strong interpersonal, influencing, presentation, and communications skills (written and verbal) to effectively address all levels within an organization
- Outstanding interpersonal skills: proven track record of building strong and sustainable relationships with internal and external partners/stakeholders
- Excellent interpersonal, communication, and negotiation skills. Proven ability to establish and maintain professional and productive working relationships
- Strong interdependent partnering ability including negotiating/influencing skills
- Strong clinical skills in primary care is required
- Excellent communication and presentation skills in English (both written and spoken)
- Strong collaborator who can effectively work as a team that consist of MDs, RNs, patient care coordinators and case/disease managers
- Clinical experience required as well as strong scientific competence demonstrated by peer reviewed publications
- Prior experience in industry roles (5+ years). Direct medical affairs experience desired
2
Skills For Global Medical Director Resume
- Prior experience in pharmaceutical industry roles. Direct medical affairs experience required
- Proficiency in data interpretation with excellent skills in oral and written communication
- Prior experience with professional claim coding / claim coding reviews is essential
- Solid understanding of regulatory requirements and ICH guidelines (including E3 and E6), and good knowledge of document management systems
- Leadership skills, creating a vision and successfully meeting goals
- Experience from clinical practice, experience in conduct of clinical trials
- Problem analysis and clinical decision-making are the most critical skills, including the ability to independently formulate and implement solutions
3
Skills For Director, Medical Information Resume
- Prior NDA/BLA/MAA submission experience, including eCTD, is required
- Prior experience in a variety of therapeutic areas
- Demonstrated supervisory and vendor management experience
- Experience in coordination and prioritization of multiple projects in a fast-paced environment
- Proficient skills in Microsoft Word, Microsoft Excel, Microsoft Outlook, Adobe Acrobat
- MBA or equivalent business skills is an asset
4
Skills For Director, Medical Group Operations Resume
- Work effectively in a team-oriented, dynamic and professional environment
- Inspiring your team, recruiting, developing and retaining talent and ensuring a strong succession plan for key positions
- Working experience with safety database Argus 8.0.x
- Proven track record in building and managing a dynamic and efficient medical writing team
- Proven track record in contributing to matrix teams in planning and production of clinical documents to support regulatory submissions
5
Skills For Director, Medical Services Resume
- Good knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements
- Experience working in a team environment and the ability to work collaboratively towards a common goal
- Requires a strong understanding of financial reports
- · Requires a strong understanding of financial reports
- Strategic thinking with proven ability to communicate a vision and drive results
- Nursing, Quality Improvement and Management experience in a healthcare environment, preferable managed care
- Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Experience developing product and safety profiles
6
Skills For Director, Medical Writing Medical Dermatology Resume
- Works well within teams and is effective in collaborating with others internally and externally
- Extensive experience in Utilization Management and Case Management in a payer setting is ideal
- Excellent, independent judgment based on leading-edge knowledge and expertise
- Four years of work experience for a Bachelors prepared applicant; preferably in a healthcare setting
- Experience in leading change within an organization
- Strong working knowledge of applicable regulations and ICH guidelines
- Experienced in data analysis and presentation, statistical analysis, as well as quality control of representative data analyses/displays against raw data
7
Skills For Senior Director, Medical Writing Resume
- Physician management, financial management and operations management experience
- Demonstrated ability to build alliances, drive results and manage change
- Experience with case management integrated health management
- Experience in case narrative preparation and analysis of similar events AOSE
- CTD submission preparation experience required
- Experience in clinical development and patient care
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
8
Skills For Medical Director, Pharmacovigilance Resume
- Experience with claims data and understanding of fee schedules, clinical programs and network design/development
- Proven expertise with a wide range of data/information: scientific/clinical, safety, legal/regulatory, medical writing, analytics, biomarkers, etc
- Experience in Cancer Immunotherapy and Cancer Immune Biology
- BS/BA +15 years, MS/MA +13 years, PhD +10 years of relevant experience in the Pharmaceutical or Biotech industry
- Experience in people management and talent development
- Contributes to pre-launch, launch and post-launch initiatives to ensure brand success and developing as well as delivering effective sales training
- Develops strong relationships with key customers (internal and external) and suppliers of medical information services
- Experience in the pharmaceutical industry within medical information and related functions is required
9
Skills For Cardiovascular Medical Director Resume
- Clinical trial experience in the pharmaceutical industry
- Ensure excellent communication and interaction within the Medical Writing team and between Medical Writing and the wider teams within Covance
- Work across departments to help set priorities for document preparation and manage consulting writers as needed to deliver documents in the required timelines
- Acting as an expert advisor to internal committees, management and teams regarding strategic medical issues and lifecycle planning
- Working with strategic governance/decision-making committees
10
Skills For Director, Medical Operations Analytics Resume
- Developing the medical vision and strategy for molecules/products across the assigned portfolio
- Representing Medical Affairs on multidisciplinary Genentech and global Roche teams
- Understanding and adherence to PMI’s or similar Project Management methodologies
- Working in global project teams
- Understanding of clinical drug development, clinical trials, and global regulatory submission regulations is desired
- Working knowledge of document management systems (eg, Documentum®)
List of Typical Responsibilities For a Director Medical Resume
1
Responsibilities For Group Medical Director Resume
- Provides guidance and oversight to department heads to lead their respective functions; ensures that operating standards and procedures are available for all medical department operations
- Strong clinical trial experience
- Provides timely inputs on an annual basis for workforce planning for direct reports and co-operates with the HR department accordingly
- More than 10 years of medical writing experience required in clinical drug development in various therapeutic areas
- Experience as a lead writer of clinical study documents and global regulatory submissions and manager of medical writing projects
- Monitor loyalty results for area of responsibility and implement Medical Group tactics to improve loyalty scores and promote a positive patient experience
- Operate in complex matrix structure
- Preferably someone with Nutrition clinical trial experience in particular PN
- Leading interactions with regulatory agencies globally as it pertains to clinical studies
2
Responsibilities For Global Medical Director Resume
- Initiates medical affairs activities, generation, and dissemination of data supporting overall product scientific and business strategy
- Provide support to clinical trial transparency reporting
- Responsible for creating strategies for an extensive US clinical trials program
- Provides medical leadership into the product marketing strategies
- Responsible for assessing core team members’ competencies and participation
- Maintains clinical and specialty expertise. Attends business team meetings, advisory board meetings, steering committee meetings
- New ORs coming to RGH in 2020!
- Aligns and implements efficiency initiatives to improve timelines and delivery of authoring documents
- Reviews reports, press releases, promotional materials and provides approvals, as appropriate
3
Responsibilities For Director, Medical Information Resume
- Acts as a role model to communicate BI’s values, as well as core technical and leadership competencies to direct reports
- Identifies issues that affect employee satisfaction and raises the issues to senior management
- Plans, manages, and reviews individual performance and provides regular informal feedback as required. Conducts formal bi-annual performance appraisals for direct reports and reports on their performance to superiors as required
- Facilitate and execute Corporate communication interface to healthcare professionals and medical associations for dissemination of medical and scientific information about Insmed’s products and therapeutic areas of interest
- Establish/enhance robust surveillance and benefit-risk processes based on clinical and scientific expertise to support Seattle Genetics’ products across the lifecycle
- Provide oversight for members of the Safety Evaluation and Risk Management (SERM) group in Drug Safety
- Establish risk management process starting early in development. Work with clinical teams to develop risk management plans to support Seattle Genetics’ regulatory submissions
- Oversee signal management and risk management of Seattle Genetics’ products on a global basis across the life cycle
4
Responsibilities For Director, Medical Group Operations Resume
- Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, SMC/IDMC Charters
- Participate in protocol development to ensure alignment with risk management plans
- MD (board certified or ex-US equivalent)
- For ex-US, has medical affairs oversight of patient level data generation activities for the Top Customers Solutions Team, ensuring they are compliant with Merck’s policies for studies. For US, has effective liaison with CORE for data generation
- Can lead advisory boards and expert input forums, as appropriate
- Leads patient level data generation activities in accordance with Merck’s policies for studies
- Assists with investigations into alleged violations and the development and implementation of disciplinary and/or corrective action as indicated
5
Responsibilities For Director, Medical Services Resume
- Continually assesses the department for compliance with all federal, state, local and other regulatory (Joint Commission, OSHA, CMS, etc.) requirements
- At least three (3) years of leadership experience at a director, manager or equivalent level, leading an medical economics, actuarial informatics, analytics, data warehousing or BI team
- At least seven (7) years of medical economics, actuarial informatics, analytics or highly impactful reporting development experience for a health provider, plan or managed care organization including either
- Writes articles for medical director’s newsletter
- Partners with assigned LOCs to drive excellence in external engagement with key stakeholders (HCP’s, Patients, Payors and Regulators). Builds strong external networks
- Lead a team of data scientists, analysts and other team members on Medical Economics analytic projects and routine reporting related to clinical informatics and population health operations
- Effectively communicate with your stakeholders and customers and ensure all requests are properly triaged, recorded and tracked. Also help staff demonstrate emotional intelligence when communicating with others
- Analyze issues using enrollment, utilization, clinical, medical management, financial and other corporate data, and information from both modeled internal data as well as disparate internal and external sources. Also help staff develop better analysis skills, understanding use cases and their value to the organization
- Adhere to corporate standards for performance metrics, data collection, data integrity, query design, and reporting format to ensure high quality, meaningful analytic output
6
Responsibilities For Director, Medical Writing Medical Dermatology Resume
- Work closely with IT on the ongoing improvement of integrated data warehouse, driven by strategic and business needs, and designed to ensure data and reporting consistency throughout the organization. Also play a key role in implementing our Population Health Management 3 rd party system as it relates to operations and analytics
- Develop and maintain project work plans, including critical tasks, milestones, timelines, interdependencies and contingencies. Track and report progress. Keep stakeholders apprised of project status and implications for completion. Also guide staff to better time and project manage
- Provide technical support to data analytics functions as they relate to varied business units, and technical expertise on the selection, development and implementation of various reporting and BI tools tied to business unit reporting requirements. Create new BI reports and interactive dashboards as required
- Discusses cases and clinical coding situations with treating providers telephonically during scheduled hours
- Reviews surgical and other professional claims for correct coding using clinical record
- Participate in Behavioral Health Consultations, Clinical Case Reviews, and Multidisciplinary Staffing’s when requested
- Ensure customers are adequately trained to use self-service BI tools and dashboards
7
Responsibilities For Senior Director, Medical Writing Resume
- Assist and teach others within the organization on how to a) define meaningful process and performance measures, b) develop BI queries, and c) generate and use management reports effectively
- Share development and process knowledge with analysts in order to assure consistency and continuously build a core of analytical strength within the organization
- Demonstrate proficiency with the principles and methodologies of process improvement. Apply these in the execution of responsibilities in support of a process focused approach
- At least three (3) years of leadership experience at a director, manager or equivalent level, leading a medical economics, actuarial informatics, analytics, data warehousing or BI team
- Maximizes use of Medical Mutual of Ohio’s business intelligence tools that support analysis and reporting of population health, provider profiling activities, and line of business product reporting
- Through data review and research, identifies for monthly Safety, Risk Management and Safety Science Management Team meetings, issues that could be potential signals for observed adverse events for further review and analysis
- Detects, validates and manages pre-and/or post-approval safety signals through to resolution
- Directs the Safety Management Team for the assigned project(s) or product(s) ensuring a safety and risk/benefit driven agenda from inception to closure
- Collaborates with external resources such as Clinical Operations and Clinical Scientist on the identification of and resolution for potential signals
8
Responsibilities For Medical Director, Pharmacovigilance Resume
- Ensures timely, accurate recording of risk management action plans and decisions, and project manages GPV deliverables as appropriate to ensure completion on time to applicable standards
- Conducts medical assessment of causality of Individual Case Safety Report (ICSR) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes in process
- Evaluates aggregate safety data and writes contributions to its interpretation for Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, IB, CCSI, Safety Summaries and Clinical Overviews for the CTD, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required
- Identifies, initiates and manages to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary
- Responds to emerging topics of interest and ensuring accurate and compliant information is provided via the Medical Information Healthcare Professional Website
- Conducts medical evaluation of issues arising from PV Operations, such as use of the MedDRA dictionary and the IME list
- Provides medical input to ARGUS search criteria as necessary, including development of appropriate searches where no SMQ exists
- Direct the work of internal medical writers and medical writing specialists. Manage external writing resources. Provide coaching and training to Pfizer colleagues to support performance management and career development
9
Responsibilities For Cardiovascular Medical Director Resume
- Work closely with Medical Writing management to establish new medical writing support models and implement strategies to improve operational efficiency. Apply relevant experience in process initiatives, technologic improvements, and/or vendor management
- Excellent project management skills. Proven ability to manage medical writing deliverables for multiple studies or programs
- Medical writing experience in protocols, CSRs, and data disclosure deliverables (e.g., ClinicalTrials.gov, EudraCT, EMA Policy 70)
- BA/BS or higher and at least 6 years of writing experience in the pharmaceutical industry
- Participate and/or lead business processes to support functional excellence, quality, and innovation
- Responsible for oversight and guidance on input into the development of marketing materials and scientific communication materials (e.g. slide decks) to support compliance and alignment with strategy
10
Responsibilities For Director, Medical Operations Analytics Resume
- Contributes to resolution of product related issues in the marketplace
- Promotes and ensures a high standard of customer service for both internal and external customers
- Identifies data to design scientific responses intended to address Health Care Professional and patient needs
- Oversees the management of the information resource center
- Develops strategy and build processes, systems and structure to support the delivery of Medical/Scientific Information services to all customers including healthcare professionals, academics, consumers and company personnel relating to products either in development or on the market
- Builds convincing clinical or regulatory arguments using logic, analogy and therapeutic area science
- Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data
- Contributes to the Medical Affairs department, including all activities undertaken by Medical Directors and medical personnel in the global arena
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