Medical Writer
3 weeks ago
REMOTE
The Medical Writer for Clinical Procedures works with Process Owners, Subject Matter Experts (SMEs), and relevant stakeholders to develop new and revise existing clinical procedures. The Medical Writer ensures procedures and associated forms and templates are written to a high-quality standard and according to client's writing style guide and standards for clinical procedures/documents. The Medical Writer manages document reviews and adjudication of review comments on procedures and associated forms and templates by liaising with the Process Owners, SMEs, and the QC reviewer. The Medical Writer drives the writing of clinical procedural documents by working across global cross-functional teams and ensures that timelines and customer/stakeholder needs are met. The Medical Writer accurately tracks timelines and status of procedural document development and review and works with the administrator of the learning management system to ensure procedures are available for training.
Requirements
• Bachelor's degree required.
• Proven medical writing experience, with at least 8 years working in the pharmaceutical industry; the ideal candidate will also have experience in writing SOPs/clinical procedures.
• A strong working knowledge of all clinical development functions and processes, compliance standards, and ICH, GCP, and regulatory requirements.
• Significant experience in applying writing style guidelines and standards.
• Customer-focused approach, with strong project management and interpersonal skills and the ability to build relationships, resolve conflicts, and obtain buy-in necessary to achieve objectives.
• Experience across multiple disciplines within clinical development in the pharmaceutical industry, with knowledge of the drug development process.
• Proven experience in developing, maintaining, and using templates and working in an electronic document management system.
• Excellent communication skills both oral and written at all levels.
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
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Medical Writer
3 weeks ago
Nutley, United States Zenith LifeScience Full timeJob SummaryThe Clinical SOP Writer edits and performs QC review of clinical procedures. The Writer may also eventually work with Process Owners, Subject Matter Experts (SMEs), and relevant stakeholders to develop new and revise existing clinical procedures. The Writer ensures procedures and associated forms and templates are written to a high-quality...
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Medical Writer
3 weeks ago
Nutley, United States Zenith LifeScience Full timeJob SummaryThe Clinical SOP Writer edits and performs QC review of clinical procedures. The Writer may also eventually work with Process Owners, Subject Matter Experts (SMEs), and relevant stakeholders to develop new and revise existing clinical procedures. The Writer ensures procedures and associated forms and templates are written to a high-quality...
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Nutley, United States Eisai, Inc. Full timeAt Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...
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Nutley, United States Eisai US Full timeAt Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...
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Nutley, United States Eisai, Inc. Full timeAt Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...
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Nutley, United States Eisai US Full timeAt Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...
