Seeking an opportunity to demonstrate my extensive experiences, broad knowledge, and technical expertise as the preferred scientific partner for providing medical and scientific support internally and externally to the company’s key products activities, research, and marketing issues through cross functional collaboration.
- Developed and maintained scientific relationships ( scientific partnerships) with External Experts to gather insights and input on treatments, gain complete understanding of the needs and behaviors of Cardiology, Oncology, Pediatrics, General Medicine, Critical Care, and Neurology(Epilepsy) health care providers, as well as scientific activities within these disciplines.
- A comprehensive range of experience and formal training in clinical pharmacy and health care administration.
- Demonstrated technical and clinical knowledge, including ability to prepare, understand, and articulate scientific study results.
- Been responsible for leading a team of field - based MSL’s with a focus on hiring recommendations, training, mentoring, developing and managing the team.
- Ensured that each new or junior MSL adhered to high scientific standards as well as corporate and regulatory compliance in all activities, including those related to clinical trials, scientific presentations, responses to unsolicited requests for information, and other interactions with Key Opinion Leaders.
- Participated in all phases of clinical trials and development process for major companies.
- Led efforts for company sponsored studies including study design, medical monitoring and medical/scientific interpretation of study analyses for both efficacy and safety.
- Participated on teams to complete clinical study safety reports and reviewed scientific and regulatory documents.
- Strong reputation for demonstrated ability to support corporate and departmental goals.
- Demonstrated leadership skills with ability to work on high performance teams and/or matrix organization.
- Developed and maintained strong working relationships with medical experts in both academic and community settings, Interventional Radiologists, Oncologists, etc.
- Disseminated scientific information to physicians, nurses, pharmacists and other healthcare professionals on state-of-the-art research and medical concepts in interventional radiology, neurology, consultant programs and one-to-one peer exchange.
- Represented company at specific continuing-education events/programs, medical meetings and conventions.
- Provided sales force with training at national and regional levels.
- Utilized scientific resources to deliver impactful presentations in a variety of different settings.
- Understands and can operate within appropriate legal and regulatory guidelines. Self-motivated, self-directing, attention to detail and excellent time management skills.
- Demonstrated ability to quickly gain knowledge of therapeutic areas, science, and products for all assigned therapeutic areas.
- Demonstrated ability to simultaneously manage numerous, complex projects with overlapping timeframes, and deadlines.
- Direct, assist, and train other medical writers in the writing, editing, and compilation of documents that are components of clinical/regulatory marketing approval applications for new drugs, biologics, or devices.
- Interact directly with physicians, scientists, statisticians, clients and contractors in a professional and organized manner to drive products through to completion.
- Compile, write, and edit regulatory documents and reports, including but not limited to briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
- Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client Confidential and style guidelines. Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client. Keep abreast of professional information and technology through workshops and conferences, and ensure the appropriate transfer of that information to the department.
Confidential, Teaneck, NJ
Senior Medical Science Liaison
- Ensured the content being developed meets the team’s needs and is both timely and relevant.
- Demonstrated appropriate territory planning and time management skills by effectively covering the specific geographical area of responsibility while achieving stated business objectives.
- Responsible for submitting annual management business objectives MBO and territory / payer business plans identifying issues and opportunities, monthly activity reports, expense reports and other reports in a timely fashion as requested.
- Partnered with Corporate counterparts in Legal, Regulatory Affairs, Marketing, and other internal teams to ensure Regulatory Policies and strategies are aligned with MSL’s business plans.
- Served as the primary contact in leading scientific and technical support for trade associations, government agencies, and professional organizations regarding company’s regulatory policy and strategy.
- Acquired and maintained expert knowledge of relevant therapy areas, client products, and objectives. Took ownership of assigned projects and programs and took independent action to resolve complex technical issues to ensure excellent project delivery. Liaised effectively with client and external authors/opinion leaders during the lifecycle of assigned projects or programs.
- Highly articulate and persuasive during formal and informal presentations; able to convey complex, scientific ideas fluently to any audience (account executives or top tier opinion leaders, non-advocate audiences, internal sales, marketing or legal staffs.
- Demonstrated ability to address educational and research needs through delivery of cutting edge scientific/evidenced based data in neurology, gastrointestinal disorders and oncology/critical care Neurology (Adult & Child) and other therapeutic areas.
- Comprehensive understanding of laws, regulations, codes, standards and guidelines regarding pharmaceutical industry practices related medical liaison activities.
Confidential, Kalamazoo, MI
Director of Pharmacy Operations
- Assessed appropriate drug information and literature resources, and provided effective information to varied audiences including patients, other health care professions, and peers.
- Solved problems in the medication use process for patients and the organization.
- Identified and engaged in organizational and department quality improvement activities to improve patient care, medication use process, and pharmacy operations.
- Educated and trained residents, students, interns, colleagues and other health care professionals as well as supervised technicians, residents, interns, or trainees in their job tasks.
Confidential, Cincinnati, OH
- Manager, Professional and Scientific Relations
- Developed and created new scientific tools and resources for new Confidential .
- Trained MSL team on resources.
- Ensured the content being developed meets the team’s needs and is both timely and relevant.
- Developed tactics for communicating complex scientific information to the healthcare community regarding Ventricular Arrhythmia Phase III program.
- Work with US operations and others in the preparation and filing of post-approval supplemental applications.
- Knowledge of clinical research, GCP, GCDMP, and related regulatory requirements.
- Managed the operational effectiveness and efficiency of clinical trials staff of the research department to assure compliance to federal, state and local regulations, protocols, and company policies.
- Created and maintained accurate Confidential and ensured adherence to Confidential .
- Trained staff on Confidential and maintained training records.
- Collaborated with the leadership team to develop site and service goals providing input related to the development and management of the budget.
- Developed policies and procedures in coordination with other leaders to support services in the provision of excellent research services.
Senior Regional Scientific Manager
- Cultivated new and nurture existing relationships with Key opinion leaders for Digestive disorders and other designated key external/internal audiences.
- Delivered high quality, cutting edge clinical/scientific presentations.
- Participated in any type of internal training format or venue according to training direction.
Confidential, Morris Plains, NJ
Medical Science Liaison
- Demonstrated ability to communicate and plan effectively across multiple company functions/departments.
- Provided review of concepts and materials for activities such as advisory boards, consultants meetings, medical education programs and use by internal personnel.
- Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.
- Knowledge of clinical drug development process including Phase 2-4 and lifecycle management.
- Maintained a high level of technical expertise through familiarity with medical and scientific literature for an assigned therapeutic area.
- Collaborated with management teams to identify training needs for team personnel to ensure compliance with Confidential policies, guidelines and processes.
- Highly motivated and capable of comprehending complex scientific/medical content which is then communicated in a clear, concise manner. Served as clinical, scientific, and educational expert for women’s health, and therapeutic benefits of women’s healthcare products.