Intra-Cellular Therapies, Inc
Associate Director/ Director, Medical Writing
Intra-Cellular Therapies, Inc, Bedminster, New Jersey, us, 07921
Intra-Cellular Therapies, Inc - Associate Director/Director, Medical Writing “We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”
If your skills, experience, and qualifications match those in this job overview, do not delay your application.Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.The Associate Director/Director of Medical Writing provides support for the planning, preparation, and submission of clinical documents, regulatory documents, and responses to health authority information requests. The Associate Director/Director of Medical Writing must have experience with preparation and QC of regulatory submissions.Responsibilities:Clinical Study Reports, including patient/subject narrativesProtocols/Protocol AmendmentsNDA/sNDA clinical modules, appendices, and referencesQC review of aforementioned documents for regulatory submissionsPerform other tasks as requested by ITI senior management, complete all company and job-related training as assigned within the required timelines.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.Requirements:Master’s degree with medical writing experience is required. A relevant advanced degree is preferred (ie, PhD, MD)Minimum 10 years of clinical research experience or equivalent combination of clinical research/medical writing experience and education; minimum 8 years of medical writing experience in the pharmaceutical industry is preferredScientific knowledge and experience in psychiatry or CNS preferred; experience in other therapeutic areas will be consideredAbility to analyze, interpret, and distill early- and late-phase clinical dataAbility to work in a document management systemProficient in Microsoft office applications (Word, Excel, PowerPoint)Demonstrated understanding of the drug development processAbility to travel at least 10%Key Stakeholder Relationships:Must be able to work in a cross-functional setting with the following teams:Regulatory AffairsClinical DevelopmentClinical PharmacologyPharmacovigilance/Drug SafetyIntra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.Associate Director, Medical Writing:
Base Salary Range $140,000 - $165,000Director, Medical Writing:
Base Salary Range $170,000 - $210,000
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If your skills, experience, and qualifications match those in this job overview, do not delay your application.Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.The Associate Director/Director of Medical Writing provides support for the planning, preparation, and submission of clinical documents, regulatory documents, and responses to health authority information requests. The Associate Director/Director of Medical Writing must have experience with preparation and QC of regulatory submissions.Responsibilities:Clinical Study Reports, including patient/subject narrativesProtocols/Protocol AmendmentsNDA/sNDA clinical modules, appendices, and referencesQC review of aforementioned documents for regulatory submissionsPerform other tasks as requested by ITI senior management, complete all company and job-related training as assigned within the required timelines.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.Requirements:Master’s degree with medical writing experience is required. A relevant advanced degree is preferred (ie, PhD, MD)Minimum 10 years of clinical research experience or equivalent combination of clinical research/medical writing experience and education; minimum 8 years of medical writing experience in the pharmaceutical industry is preferredScientific knowledge and experience in psychiatry or CNS preferred; experience in other therapeutic areas will be consideredAbility to analyze, interpret, and distill early- and late-phase clinical dataAbility to work in a document management systemProficient in Microsoft office applications (Word, Excel, PowerPoint)Demonstrated understanding of the drug development processAbility to travel at least 10%Key Stakeholder Relationships:Must be able to work in a cross-functional setting with the following teams:Regulatory AffairsClinical DevelopmentClinical PharmacologyPharmacovigilance/Drug SafetyIntra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.Associate Director, Medical Writing:
Base Salary Range $140,000 - $165,000Director, Medical Writing:
Base Salary Range $170,000 - $210,000
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