Medical Writer/SOP Writer/Pharma

3 weeks ago

Nutley, United States Maxis Clinical Sciences Full time
Job DescriptionJob Description

Description:
(Contract) Job Title: Clinical SOP Writer

Job Summary:
The 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 standard and according to Client's writing style guide and to standards for clinical procedures/documents.

Requirements:
• Bachelor's degree in English or related subject, or Bachelor's degree in science with proven writing experience.
• Experience in pharmaceutical industry; knowledge of clinical development.
• Proven writing, editing, and quality control review experience.
• Proficiency in MS Word and Excel.
• Considerable experience in applying writing style guidelines and standards
• A strong working knowledge of all clinical development functions and processes, compliance standards, and ICH, GCP, and regulatory requirements.
• Customer-focused approach, with strong project management, multitasking, and interpersonal skills.
• 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 electronic templates and working in an electronic document management system.
• Excellent communication skills both oral and written at all levels.

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.

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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