What are the responsibilities and job description for the Nonclinical Regulatory Writing and Submission Support, Sr. Manager Job at Takeda position at Takeda Pharmaceutical?
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Job Description
OBJECTIVES / PURPOSE
Develop, manage, and execute nonclinical regulatory writing in a variety of projects of diverse scope and complexity across multiple therapeutic areas, geographic regions and development phases.
Champion continuous improvement by integrating automation and innovative practices into the technical and regulatory writing framework, streamlining processes and fostering an environment of forward-thinking excellence.
Serve as the NRWS representative on cross-functional initiatives, when required.
ACCOUNTABILITIES
Plan, author, review, update and manage nonclinical components of regulatory documents such as Briefing Books (BB), Investigator's Brochures (IBs), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biologic License Applications (BLAs), Marketing Authorization Applications (MAAs), and various annual reports for drug products across Takeda's R&D portfolio and major therapeutic areas.
Apply advanced knowledge and experience to assess document requirements, develop writing strategy, compose drafts, identify information gaps, and facilitate document finalization for regulatory-compliant submissions.
Understand and apply the principles of regulatory writing and lean authoring, writing with the audience in mind and conveying messages in a clear and concise manner.
Lead nonclinical submission working groups to liaise effectively with cross-functional team members to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
Represent NRWS on cross-functional teams to plan, generate, manage, finalize and communicate about nonclinical documents for regulatory submissions.
Implement and drive continuous improvement by integrating automation, innovative practices and new technologies into the technical and regulatory writing framework.
Develop practical timelines for deliverables.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :
Ph.D. or M.Sc. in scientific field (e.g., biology, pharmacology, toxicology), with minimum of 8 years of experience with nonclinical regulatory writing within the pharmaceutical industry or Contract Research Organization (CRO).
Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions.
Experience in drug product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics.
Experience in program management, with ability to prioritize and manage multiple programs within strict regulatory / compliance deadlines.
Thorough understanding of regulatory guidelines related to global submissions and submission content.
Forward thinking and passionate about driving innovation and continuous improvement.
Demonstrate Digital Dexterity.
Details oriented with strong verbal, written, and interpersonal communication skills.
Possession of innovative problem-solving skills.
Ability to operate in a fast-paced environment and manage multiple activities, priorities, and deadlines.
Ability to rapidly adjust to new, unknown, and / or challenging situations.
Demonstrated ability to work in a global ecosystem with a high degree of complexity.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees.
For Location : Massachusetts - Virtual
U.S. Base Salary Range : $133,000.00 - $209,000.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for various benefits including medical, dental, vision insurance, and paid time off.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
LI-Remote
J-18808-Ljbffr
Salary : $133,000 - $209,000
