Senior Medical Writer (Irvine)

Senior Clinical Research ScientistJob Description:This professional will report to Clinical Science and External Research (CSER) Leaders in the management of assigned clinical projects for the Cardiovascular Group to support the development of the evidence generation and dissemination strategy of assigned products, manage clinical studies, execute publication plans, and conduct literature reviews. S/he will manage activities with supervision consistent with level of experience. S/he will be responsible for providing support activities for clinical activities and other study-related tasks, as well as applicable department study-related procedures.The Senior Clinical Research Scientist will or may be responsible for:Working with Global Strategic Marketing, Franchise Clinical Leaders, Biostatistics, Data Management, Medical Affairs, and other functions on: (i) planning and executing research collaborations with physicians, (ii) tracking study idea development and progress, and (iii) planning data dissemination via congress presentation and peer-reviewed publicationsManaging nonregulated studies (eg, Investigator initiated, Registries, Real-world evidence, Company -sponsored postmarket studies) and low complexity regulated studies (eg, Postapproval, Real-world evidence) including study budget assessment, fair market value appraisal, contract development and execution, and paymentsInterfacing and collaborating with investigators, IRBs/ECs, Competent Authorities, contractors/vendors, and Company personnelDeveloping study-related materials (eg, protocol, CRFs, CSR)Analyzing, interpreting, summarizing, and sharing appropriate interpretation of clinical evidence generated from research studiesLeading study-related publication efforts including abstracts, congress presentations, and manuscripts, per clinical publication policyCollaborating with cross-functional team members to develop collaterals to disseminate research results among internal and external stakeholdersKnowing, understanding, incorporating, and complying with all applicable laws and regulations relating to business activities, and Policies and ProceduresEvaluating publication support requests and providing meaningful, consolidated comments during the publication development lifecycleTracking assigned project budgets to ensure adherence to business plansCommunicating progress towards planned timelinesAdditional Skills Requirements:Effective time management, organizational and prioritization skills, and the ability to manage multiple tasksStrong project management skills with meticulous attention to detail and accuracyProfessional verbal and written communication skillsProven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently, as neededMust be reliable, and flexible in adapting to shifting business needs while contributing to a multidisciplinary and fast-paced working environmentMust be a highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of his/her contributions to the advancement of the collective CSER goals and objectivesProficient in Microsoft OfficeQualifications:A minimum of a Bachelor's degree with at least 5 years of clinical research experience requiredAdvance degree (Master's degree, PhD, PharmD etc.) with 2-3 year of clinical or related research experience highly preferredA Life Science, Physical Science, Nursing, or Biological Science degree is preferredAbility to analyze and interpret scientific data and advanced writing/presentation skills are required, such as conducting literature reviews, and planning and drafting conference presentation and peer-reviewed journal articlesKnowledge of Good Clinical Practices and ICJME/Good Publication Practices is requiredGpp3, ISMPEE – highly preferredGood understanding of clinical research science and processes along with an understanding of product development processes, team dynamics related to healthcare market environment, and global clinical trial regulations is preferredPrior experience designing and executing clinical studies is highly desirableProject management skills with the ability to handle multiple projects is requiredMedical device experience is requiredCardiovascular experience is highly preferredRelevant industry certifications preferred (ie, CCRA, RAC, CDE, CMPP, MWC)This position is located in Irvine, CA