Takeda Pharmaceuticals
Associate Director, Nonclinical Regulatory Writing and Submission Support
Takeda Pharmaceuticals, Juneau, Alaska, us, 99812
Associate Director, Nonclinical Regulatory Writing and Submission Support
Location:
Juneau, Alaska (Remote)
The following information provides an overview of the skills, qualities, and qualifications needed for this role.At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Are you looking for a patient-focused, innovation-driven company that enables you to engage in meaningful work? Join us as an Associate Director - Nonclinical Regulatory Writer and Submission Support reporting to the Nonclinical Regulatory Writing and Submission Support,
GI2 and NS Products
Team lead.How you will contribute:Provides nonclinical regulatory writing expertise and mentorship to NRWS and Research and Development (R&D) staff members.Involves in a variety of projects of diverse scope and complexity, across all developmental stages (pre-development through post-marketing) with focus on Gastrointestinal and Inflammation (GI2) and Neuroscience (NS) Products.Applies advanced knowledge and experience to assess document requirements, develop writing strategy, compose drafts, identify information gaps, and facilitate document finalization for submissions.Plans, authors, revises, updates and manages nonclinical components of regulatory documents such as Briefing Books (BB), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Investigator's Brochures (IBs), New Drug Applications (NDAs), and Biologic License Applications (BLAs).Analyzes, interprets, and distills nonclinical data to independently write and/or edit nonclinical documents.Leads nonclinical submission working groups to liaise effectively with cross-functional team members.Represents NRWS on cross-functional project teams to plan and communicate about nonclinical regulatory submissions.Serves as the NRWS representative on cross-functional initiatives, when required.Minimum Requirements/Qualifications:Ph.D. in scientific field (e.g., pharmacokinetics, pharmacology, toxicology), with minimum of 10 years of leadership experience with nonclinical regulatory writing.Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics.Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions.Experience in drug product development across numerous modalities.Experience in program management, with ability to prioritize and manage multiple programs.Strong verbal, written, and interpersonal communication skills.ADDITIONAL INFORMATIONThe vast majority of project meetings are scheduled based on Eastern Time standard working hours (8am – 5pm ET). Although this position is remote, occasional face-to-face meetings may be important to attend (no more than quarterly, likely in Boston, MA).Takeda Compensation and Benefits SummaryU.S. Base Salary Range: $108,500.00 - $170,500.00EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment.
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Location:
Juneau, Alaska (Remote)
The following information provides an overview of the skills, qualities, and qualifications needed for this role.At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Are you looking for a patient-focused, innovation-driven company that enables you to engage in meaningful work? Join us as an Associate Director - Nonclinical Regulatory Writer and Submission Support reporting to the Nonclinical Regulatory Writing and Submission Support,
GI2 and NS Products
Team lead.How you will contribute:Provides nonclinical regulatory writing expertise and mentorship to NRWS and Research and Development (R&D) staff members.Involves in a variety of projects of diverse scope and complexity, across all developmental stages (pre-development through post-marketing) with focus on Gastrointestinal and Inflammation (GI2) and Neuroscience (NS) Products.Applies advanced knowledge and experience to assess document requirements, develop writing strategy, compose drafts, identify information gaps, and facilitate document finalization for submissions.Plans, authors, revises, updates and manages nonclinical components of regulatory documents such as Briefing Books (BB), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Investigator's Brochures (IBs), New Drug Applications (NDAs), and Biologic License Applications (BLAs).Analyzes, interprets, and distills nonclinical data to independently write and/or edit nonclinical documents.Leads nonclinical submission working groups to liaise effectively with cross-functional team members.Represents NRWS on cross-functional project teams to plan and communicate about nonclinical regulatory submissions.Serves as the NRWS representative on cross-functional initiatives, when required.Minimum Requirements/Qualifications:Ph.D. in scientific field (e.g., pharmacokinetics, pharmacology, toxicology), with minimum of 10 years of leadership experience with nonclinical regulatory writing.Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics.Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions.Experience in drug product development across numerous modalities.Experience in program management, with ability to prioritize and manage multiple programs.Strong verbal, written, and interpersonal communication skills.ADDITIONAL INFORMATIONThe vast majority of project meetings are scheduled based on Eastern Time standard working hours (8am – 5pm ET). Although this position is remote, occasional face-to-face meetings may be important to attend (no more than quarterly, likely in Boston, MA).Takeda Compensation and Benefits SummaryU.S. Base Salary Range: $108,500.00 - $170,500.00EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment.
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