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Senior Medical Writer
2 months ago
Eastridge Workforce Solutions is a prominent provider of workforce management solutions, dedicated to linking skilled professionals with significant career paths. We are currently seeking a Senior Medical Writer for a client that is continually addressing challenges in the field of neuroscience to provide innovative and essential solutions.
Key Responsibilities:
- • Serve as the primary medical writing contact for the creation of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents required for regulatory submissions.
- • Engage in and contribute to the formulation of the submission communication strategy for a product.
- • Accurately interpret and summarize data from biostatistical summary tables and listings into concise narrative text.
- • Collaborate with internal teams, including Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations, and R&D Management to gather necessary information and ensure timely execution of report production activities.
- • Oversee, coordinate, and review the work of other medical writers, including freelance and contract medical writers, with support from the Director of Medical Writing.
- • Promote innovation and enhancements related to medical writing processes and documentation, with guidance from the Director of Medical Writing.
- • Undertake additional responsibilities as assigned.
Qualifications:
- • Minimum of 3 years of experience in medical writing within the pharmaceutical sector, focusing on regulatory document preparation; familiarity with the drug development process and regulatory guidelines.
- • Proven ability to independently manage projects and lead, organize, or participate in cross-functional teams.
- • Background in journalism or press publications.
Essential Skills:
- • Exceptional writing skills with the capability to transform scientific data into a clear, scientifically sound, and well-structured narrative.
- • Proficient in self-editing and enhancing personal work to ensure clarity, accuracy, consistency, and appealing presentation of data and information.
- • Understanding of clinical trial and drug development processes.
- • Knowledge of and/or ability to swiftly grasp US, ICH, and international regulations, requirements, and guidance related to scientific and clinical/regulatory document preparation and submissions.
- • Familiarity with Common Technical Document content templates and 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.
- • Strong proficiency in software applications in a Windows environment, particularly in word processing, flow diagrams, and spreadsheets.
- • Quick learner with the ability to grasp the 'essence' of a narrative swiftly to convert relevant scientific data/information into high-quality summaries and reports.
- • Open to constructive feedback and suggestions for improvement.
- • Skilled at effectively conveying in-depth knowledge to all levels within and outside the organization.
- • Capable of fostering a collaborative team environment.
- • Able to objectively assess situations and recommend changes based on overall project demands.
Preferred Qualifications:
- • Specific experience with CNS/Neuroscience compounds.
Benefits: For more information about the benefits available to Eastridge's temporary employees, please refer to the provided link. Occasionally, Eastridge's clients may offer additional benefits to Eastridge employees while on assignment. Details regarding 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.
Note: 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.
