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Manager / Senior Manager, Scientific Writing - Submissions Lead

Cambridge, Massachusetts

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Manager / Senior Manager, Scientific Writing - Submissions Lead

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Job ID R0023405 Date posted 09/28/2020 Location Cambridge, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Nonclinical Submissions Lead in our Cambridge, MA office.

At 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.

Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES:
The Manager, Submission Lead/Senior Submission Lead in the Nonclinical Regulatory Writing and Submissions (NRWS) group within Preclinical and Translational Sciences (PTS) is responsible for the generation and management of nonclinical regulatory submission components for compounds in Takeda’s Research and Development portfolio across all developmental stages (pre-development through post-marketing) and Takeda’s major therapeutic areas (eg, Oncology, Gastrointestinal, Neuroscience, Rare Disease).
•    The Manager, Submission Lead/Senior Submission Lead will be involved in a variety of projects of diverse scope and complexity, reflecting the of breadth of Takeda’s portfolio. The NRWS team is a very goal- and customer-driven team, and the incumbent will contribute to this collaborative and dynamic environment, bringing experience to add further value to the NRWS contribution to the PTS organization,
•    As a NRWS Submission Lead, the individual will represent NRWS on cross-functional teams, and will lead the nonclinical submission subteams, working in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism and pharmacokinetics (DMPK), drug safety research and evaluation (DSRE) functions and external collaborators. The Manager, Submission Lead/Senior Submission Lead is responsible for the planning, management, authoring and delivery of high-quality nonclinical summary components to support all regulatory submissions globally in accordance with the regulatory strategy developed by GRA (eg IB, briefing books, IND/CTA, CAC-SPA, RMP, periodic reports, PIP, NDA/MAA/BLA).
•    The Manager, Submission Lead/Senior Submission Lead will provide nonclinical regulatory expertise and mentorship to members of NRWS and may take on a supervisory role for other members of NRWS, vendors, contractors and/or consultants. The individual may lead or support training initiatives within the group and will support maintenance of a balanced workload among NRWS Submission Leads. May serve as the NRWS representative on cross-functional initiatives.

ACCOUNTABILITIES:
50-70%    Lead the planning, tracking, compilation and regulatory compliance of nonclinical documentation for regulatory submissions:
•    Submission Lead/NRWS representative on multiple project team across multiple therapeutic areas. For each assigned compound, manage all nonclinical content for global submissions.
•    Represents NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs, Regulatory Operations) to plan, generate, manage, and finalize nonclinical documents for regulatory submissions. Generates nonclinical timelines. Liaises effectively with cross-functional team members to communicate aims, content requirements, and timelines.
•    Interpret nonclinical data to independently author and/or edit nonclinical documents. Ensure alignment with ICH guidelines.
•    Works closely with SMEs from DSRE, DMPK, Drug Discovery units and Therapeutic Area units to ensure appropriate input, review, and finalization of regulatory submission documentation activities in alignment with NRWS and Takeda processes.
20-40%    Training and oversight of fellow NRWS Submission Leads.
•    Trains and mentors fellow Submission Leads to foster development, proficiency in role, and effective collaboration across network
•    Demonstrates positive leadership - emphasize teamwork and commitment, provide encouragement and resolution to fellow Submission Leads in a highly dynamic environment
10%    Responsible for developing and maintaining process and quality standards for the format and content of nonclinical documents.
•    May engage in cross-functional initiatives across the Takeda organization, including representing NRWS on company-wide documentation initiatives (eg, Global Core Dossier, EDMS, effective submission planning)
•    Maintains awareness of changes in global Regulatory Authority nonclinical documentation requirements/expectations and ensures that Takeda’s standards are compliant; may provide training and ensure alignment for PTS teams
•    Supports application of Takeda standards for documentation, document transfer, version control and archiving within PTS and by external vendors.

SCOPE OF SUPERVISION:
Employees    Potentially up to 4    

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
•    College degree B.S./M.S. preferably in scientific field (eg, biology, pharmacology, toxicology), and/or Regulatory field and/or related biomedical discipline.  Bachelor’s degree with 6+ years pharmaceutical or related experience or Master’s/PhD with 3-4 years pharmaceutical or related experience.
•    Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process.  
•    Significant experience in direct authoring of nonclinical summary sections and other components to support regulatory submissions, including but not limited to IB, briefing books, IND, CAC-SPA, periodic reports, NDA/MAA/BLA/J-NDA, and agency responses.
•    Experience with regulatory submissions for new modalities (eg: cell therapies, gene therapies, biologics) an advantage
•    Experience in a program management-type role; ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to Regulatory submission aims
•    Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g. FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements)
•    Fluency in written and spoken English is required.

Key Skills, Abilities, and Competencies

•    Highly organized; excellent attention to detail; proactive in identifying and developing solutions to problems; ability to simultaneously manage multiple tasks; works well under pressure
•    Excellent communications skills with colleagues at all levels; sense of urgency; good judgment; and a team player.
•    Ability to quickly learn technical components of systems & software, to contribute to process review, and create efficiencies to support staff

Complexity and Problem Solving
•    Ability to quickly and efficiently resolve planning conflicts, manage multiple projects simultaneously and deal with rapidly changing priorities.
•    Contribute to an environment of open communication, accountability and trust within department.
•    Works largely autonomously under general direction.  
•    Develop strategies for nonclinical submissions with relevant program teams and PTS functional leads and obtain line alignment and approval.
•    Notify line management of significant deviations from plans.
•    Ability to rapidly assimilate/synthesize data and information from diverse sources, make judgments on complex/abstract problems and develop innovative solutions as necessary.

WHAT TAKEDA CAN OFFER YOU: 
•    401(k) with company match and Annual Retirement Contribution Plan
•    Tuition reimbursement Company match of charitable contributions
•    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

Empowering Our People to Shine

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as needed) develop solutions to complex problems with cross-functional scope.

Internal and External Contacts
Accountable to Head of NRWS.  Engagement and frequent contact required with the following internal and external groups:

Internal:  Staff within NRWS, PTS, Pharmaceutical Sciences, Regulatory Affairs, Regulatory Operations, Clinical Development, Clinical Operations, Project Management, Quality Analytical Compliance, Global Patient Safety and others.  Non-R&D staff in Process Development, Quality Legal, Finance, Center for External Innovation, others as needed.

External:  PTS vendors/CROs, scientific experts, contractors & consultants.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023405

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