Open Positions

Description

The Medical Safety Physician will take on roles involving the provision of medical and scientific judgment in the evaluation of data pertaining to the efficacy and safety of the company products including, but not limited to, the following:

• Prepare safety reports/documents, such as PBRER-PSURs, Benefit-Risk evaluations, and Risk Management Plans. Ensure the accuracy of the information presented.
• Review medical safety signals and ensure proper disposition and documentation. Review data from the company post-marketing database and related pharmacovigilance sources, as needed.
• Provide support in the preparation and conduct of cross-functional meetings which involve the medical safety organization (e.g., Safety Management Team meetings). Perform tasks hands-on as an individual contributor
• Provide leadership, mentoring, and guidance to other MSP/MSS including oversight of day-to-day activities and safety report content development
• Thoroughly understand and communicate stakeholder requirements to appropriate team members, and manage all requirements accordingly to realize each for the stakeholder
• Establish clear ownership for project tasks, ensure that team members have the tool needed, and provide timely feedback
• Coordinate and facilitate delivery of project objectives
• Assess project issues and identify solutions to meet productivity, quality, and customer goals
• Track progress, review project tasks, and prepare compliance metrics to make certain deadlines are met appropriately
• Maintain timelines and target dates
• To deliver any other task and/or responsibilities that may be assigned from time to time.

Requirements

• Ideal candidate must be a board-certified medical physician

Years of Experience

• 2 years of clinical experience in pharmaceutical medicine is required

Skills

• Technical skills: ability to analyze, interpret and present complex in a concise and understandable scientific manner, both orally and in written format, is essential
• Attention to detail; diligence in record-keeping and records organization; ability to manage a high workload and critical issues; computer-literate and proficient in MS Office applications
• Interpersonal skills: team player; display initiative; strong communication and presentation skills
• Internal and external networking skills: strong collaborative and interpersonal skills; results-oriented and able to independently create and deliver; ability to thrive in a global; cross-functional environment

Description

The Medical Writer plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects.

Requirements

• Participates in the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area
• Prepares, writes, and edits creditable systematic literature reviews through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices
• Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes
• Performs data extraction of included studies into a data collection tool (e.g. Microsoft Excel, Distiller)
• Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS)
• Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports
• Organizes clinical data from literature into references, graphics, tables, and data listings
• Critically synthesizes clinical data being considered for presentation in the final report
• Performs scientific writing of the synthesized literature using templates
• Interprets and summarizes complex results from the medical and scientific literature and present them in clear, concise, and scientifically accurate manner to various end users requiring the ability understand and interpret statistical results of clinical studies
• Presents the results of systematic literature reviews at internal meetings