Job Description

Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. Eastridge is seeking a Medical Writer III for a company that constantly faces challenges in neuroscience to deliver innovative and vital solutions.

Responsibilities:

• • Acts as a medical writing point person for the production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions.
• • Participates in and contributes to the development of the submission communication strategy for a product.
• • Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text.
• • Liaises with internal groups, i.e., Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations and R&D Management to obtain necessary information and to ensure the timely implementation of activities related to the production of reports.
• • Interacts with and oversees, coordinates and reviews the work of other medical writers, including freelance/contract medical writers and agencies, with support from Director Medical Writing.
• • Fosters innovation and improvement related to medical writing processes and documents, with support from Director Medical Writing.
• • Other responsibilities as assigned.

Requirements:

• • 3+ years’ in medical writing for the pharmaceutical industry, with a focus on regulatory document preparation; knowledge of drug development process and regulatory guidelines.
• • Ability to manage projects independently and lead/organize/participate in cross-functional teams.
• • Journalism/press publications.

Must possess:

• • Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured ‘story’.
• • Ability to self-edit and improve own work to ensure readability, accuracy, consistency and aesthetic presentation of data and information.
• • Knowledge of clinical trial and drug development processes.
• • Knowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissions.
• • Knowledge of Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation.
• • Working knowledge of current electronic document management systems and publishing systems.
• • Ability to assimilate, interpret and translate information/data for appropriate audiences.
• • Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets.
• • Ability to learn fast, grasp the 'essence' of a story quickly to convert relevant scientific data/information into high quality summaries and reports.
• • Open to feedback and suggestions and innovation for improvement.
• • Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
• • Skilled at creating a cooperative team environment.
• • Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.

Preferred requirements:

• • Specific experience working with CNS/Neuroscience compounds.

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Benefits : Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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