Manager, Regulatory Publishing and Submission Management

Company: Takeda Pharmaceutical
Location: Saylorsburg
Posted on: November 21, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as -a Manager, Regulatory Publishing and Submission Management to be based -in Zurich. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVES: This key position is part of Global Regulatory Operation (GRO) and reports to the Associate Director/Director, Publishing and Submission Management. - The Manager, Regulatory Submissions Publishing 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. - The incumbent 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. - Additionally, the incumbent will 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.ACCOUNTABILITIES:

• 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 stakeholdersIdentify activities and business processes in need of improvement and consider potential solutions or new ways of working using standard proceduresEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
  • 6 + years of experience in pharmaceutical/biotech industry, with 4+ years of hands-on global regulatory submissions management and publishing experience.
  • 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.
  • 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
  • Understanding of relationship management with demonstrated experience in partnering in large scale situations
  • Business analytics experience and innovative thinking in order to drive insights into operations and change management and support strategic sourcing decisions.
  • Expert at motivating individuals and teams to manage the change aspects of implementing a new, outsourced model.
  • Must have proven track record to be able to think critically, strategically, independently and problem solve
  • Must have high level of motivation, drive, and demonstration of Takeda's leadership values
  • Excellent written and verbal communication skills
  • Top notch interpersonal skills in difficult situations
  • Ability to work seamlessly with all levels of personnel
  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
  • Excellent word processing, sharepoint, excel, e-mail, and online meeting tool skillsWHAT TAKEDA CAN OFFER YOUAt Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering Our People to ShineDiscover more at takedajobs.comAt our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have? LocationsZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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