Tbwa Chiat/Day Inc
Director, Documentation Lead - Medical Writing Hybrid, New Haven - Headquarters,
Tbwa Chiat/Day Inc, Hartford, Connecticut, United States,
Director, Documentation Lead - Medical Writing
Hybrid, New Haven - Headquarters, RemoteArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and 'undruggable' targets, the company has three investigational clinical-stage programs currently enrolling: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102 for the treatment of patients with neurodegenerative disorders; and ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas.A Documentation Lead in Medical Writing is responsible for development and management of medical writing deliverables that support the R&D portfolio and is capable of working independently to achieve goals. The Director, Documentation Lead is responsible for leading a program or TA or department while managing documents for global submissions, ensuring consistency, assigning resources, and managing/mentoring writing resources as required in order to execute on the writing deliverables across the R&D portfolio.Key responsibilities of this role include, but are not limited to:LeadershipServe in a supervisory role as Program/Submission Lead, developing strategic plans and managing projects in support of regulatory submissions, nonclinical and clinical deliverables.Apply in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects.Support production of high-quality and timely documentation in line with expectations.Medical WritingDemonstrate mastery of complex writing assignments across therapeutic areas or multiple projects.Coordinate and author key regulatory documents ensuring the integration of scientific, medical, and regulatory input from development team members.Provide support for MW team and accountability for high quality deliverables.Supervising and Maintaining StandardsProvide guidance for other medical writers and cross-functional teams regarding medical writing processes, standards, and initiatives.Supervise medical writers and contractors.QualificationsMinimum of PhD or advanced academic degree with 10+ years of experience in the research, medical, pharmaceutical, or biotechnology industry.Minimum of 3 years in a supervisory role leading medical writers.Excellent oral and written communication and project management skills.Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.EducationBachelor’s Degree Required, Advanced Degree preferred.Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families.Arvinas is an Equal Opportunity Employer.
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Hybrid, New Haven - Headquarters, RemoteArvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and 'undruggable' targets, the company has three investigational clinical-stage programs currently enrolling: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102 for the treatment of patients with neurodegenerative disorders; and ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas.A Documentation Lead in Medical Writing is responsible for development and management of medical writing deliverables that support the R&D portfolio and is capable of working independently to achieve goals. The Director, Documentation Lead is responsible for leading a program or TA or department while managing documents for global submissions, ensuring consistency, assigning resources, and managing/mentoring writing resources as required in order to execute on the writing deliverables across the R&D portfolio.Key responsibilities of this role include, but are not limited to:LeadershipServe in a supervisory role as Program/Submission Lead, developing strategic plans and managing projects in support of regulatory submissions, nonclinical and clinical deliverables.Apply in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects.Support production of high-quality and timely documentation in line with expectations.Medical WritingDemonstrate mastery of complex writing assignments across therapeutic areas or multiple projects.Coordinate and author key regulatory documents ensuring the integration of scientific, medical, and regulatory input from development team members.Provide support for MW team and accountability for high quality deliverables.Supervising and Maintaining StandardsProvide guidance for other medical writers and cross-functional teams regarding medical writing processes, standards, and initiatives.Supervise medical writers and contractors.QualificationsMinimum of PhD or advanced academic degree with 10+ years of experience in the research, medical, pharmaceutical, or biotechnology industry.Minimum of 3 years in a supervisory role leading medical writers.Excellent oral and written communication and project management skills.Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.EducationBachelor’s Degree Required, Advanced Degree preferred.Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families.Arvinas is an Equal Opportunity Employer.
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