Senior Medical Writer

Senior Clinical Research Scientist

Job 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 publications
• Managing 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 payments
• Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities, contractors/vendors, and Company personnel
• Developing study-related materials (eg, protocol, CRFs, CSR)
• Analyzing, interpreting, summarizing, and sharing appropriate interpretation of clinical evidence generated from research studies
• Leading study-related publication efforts including abstracts, congress presentations, and manuscripts, per clinical publication policy
• Collaborating with cross-functional team members to develop collaterals to disseminate research results among internal and external stakeholders
• Knowing, understanding, incorporating, and complying with all applicable laws and regulations relating to business activities, and Policies and Procedures
• Evaluating publication support requests and providing meaningful, consolidated comments during the publication development lifecycle
• Tracking assigned project budgets to ensure adherence to business plans
• Communicating progress towards planned timelines

Additional Skills Requirements:

• Effective time management, organizational and prioritization skills, and the ability to manage multiple tasks
• Strong project management skills with meticulous attention to detail and accuracy
• Professional verbal and written communication skills
• Proven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently, as needed
• Must be reliable, and flexible in adapting to shifting business needs while contributing to a multidisciplinary and fast-paced working environment
• Must 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 objectives
• Proficient in Microsoft Office

Qualifications:

• A minimum of a Bachelor’s degree with at least 5 years of clinical research experience required
• Advance degree (Master’s degree, PhD, PharmD etc.) with 2-3 year of clinical or related research experience highly preferred
• A Life Science, Physical Science, Nursing, or Biological Science degree is preferred
• Ability 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 articles
• Knowledge of Good Clinical Practices and ICJME/Good Publication Practices is required
• Gpp3, ISMPEE – highly preferred
• Good 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 preferred
• Prior experience designing and executing clinical studies is highly desirable
• Project management skills with the ability to handle multiple projects is required
• Medical device experience is required
• Cardiovascular experience is highly preferred
• Relevant industry certifications preferred (ie, CCRA, RAC, CDE, CMPP, MWC)
• This position is located in Irvine, CA