Manager, Regulatory Submissions Publishing in Helena, Montana
About the 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 four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Manager, Regulatory Submissions Publishing where you will support global processes; executing end-to-end submission assembly which includes publishing, quality control verification, finalization and delivery. This requires collaborative interaction with component providers and submission managers to ensure quality, right first time output and timeliness. You will assume the role of lead publisher for larger, complex submissions (e.g. original marketing applications), which will include coordination of all publishing-related activities and delegation of activities to other publishers.
You will also take the lead in the development of administrative documentation, provide inter-departmental and/or external stakeholder mentoring, and play an integral role in the testing and implementation of new systems, tools, and processes. As part of the Submissions Publishing, you will report to the Global Head Submissions Publishing and work with a variety of stakeholders.
How you will contribute:
Plans and manages detailed publishing timelines; provides reporting on publishing status to key stakeholders.
Proactively escalates publishing concerns, risks and issues that may delay/impact the submission and presents risk mitigation for publishing strategy.
Collaborates with other functional managers to develop strategies to mitigate risks to timelines and other issues
Keeps abreast of fluency with regulatory agency submission, publishing and validation standards to ensure compliant, valid dossiers in core regions and emerging markets.
When necessary and appropriate, steps in for or lends assistance to individual contributor direct reports to help drive results and achieve objectives.
Work closely with content providers to produce high quality submission-ready documents that adhere to internal and external electronic submission guidelines
Ensure submission documents meet the level of technical integrity required for Takeda publishing tools
Provide authors with formatting assistance as needed, as well as guidance with regards to publishing and referencing processes
Identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of submissions
Assist with departmental metrics by tracking status of projects, day-to-day production activities, and publishing anomalies
Assist with the development of publishing processes and/or documentation as needed, including user acceptance testing for new or updated publishing tools
Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders
Identify activities and business processes in need of improvement and consider potential solutions or new ways of working using standard procedures
Bachelor of Science Degree in Technical Discipline such as Life Sciences or Health Care Professions (Engineering, Biology, Chemistry, Nursing, Pharmacy) or related discipline; Advanced degree preferred.
At least 6 years of experience in pharmaceutical/biotech industry, with 4 years of hands-on global regulatory submissions management and publishing experience.
Fully understands regulatory publishing and electronic document management systems
Master knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
Expert working experience of CTA’s, INDs, orphan drug applications (ODA), CTD dossiers for MAAs, national submissions, MRP/DCP and centralized procedures. Including post marketing submissions such as variations, renewals, labeling etc.
Significant experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
Experience with supporting and leading successful delivery of projects (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change / transformation projects
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Work Paths
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Base Salary Range: $102,200 – $146,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Massachusetts - Virtual