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Submission Ready Sr Specialist

応募後で応募 求人ID R0033322 掲載日 06/15/2021 Location:Lexington, Massachusetts; Boston, 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 Submission Ready Sr. Specialist in our Lexington, 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.

Under the direction of the Head of CMC Submissions, the SRS Sr. specialist is responsible for providing Submission Ready Standard Application during the preparation of high quality regulatory submissions and a wide range of supporting documentation across the drug development lifecycle including pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, Briefing Books, Post- Approval changes or compliance updates across all global franchises. In addition the SRS Specialist will also be expected to drive, support and contribute to broader improvement initiatives that contribute to Takeda's overall success.

ACCOUNTABILITIES

SRS Application

  • Undertake document formatting to ensure consistency with company and health authority submission ready standards.
  • Review documents for submission-readiness and conformity company and health authority guidelines.
  • Undertake the submission build activities for both paper and electronic regulatory submissions, ensuring submissions are built with submission-ready documents, creating intra-document links, performing quality check and validating compiled submissions, and finalizing submission by required dispatch date.
  • Load documents into EDMS and concatenation as required
  • Provide training of authors/reviewers through guidance and expertise of system and tools for  efficient authoring and review process
  • Create, review, and/or maintain CMC submission templates
  • Maintain team compliance with company trainings and internal processes and standards
  • Collates source documents pertaining to regulatory filings/submissions on request
  • On occasion will QC selected CMC sections of regulatory filings

General

  • Project team participation as necessary, information gathering, progress reports and presentations etc.
  • Proactively seeks input, feedback and assessment from key stakeholders to drive business improvements
  • Assists in the development and implementations of departmental processes, procedures and policies.
  • Active promoter of talent, knowledge sharing and collaborative spirit

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)

  • Working knowledge of current regulations
  • Familiarity with CTD format and content of regulatory filings
  • Strong IT skills

Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)

  • Ability to effectively negotiate multiple workstreams, IT applications, projects and teams simultaneously
  • Strong team player
  • Flexibility in working hours to meet customer requirements

Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

  • Detail-oriented
  • Excellent organization skills
  • Identify issues that may delay timely completion of CMC sections and escalate as needed

Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

  • Job is accountable to the line manager and CMC Leads. Liaises with multiple cross-functional teams within Takeda and external Takeda partners.

Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

  • Flexibility to support the department in all critical business needs and organizational objectives
  • Solution driven
  • Drive and energy to multi-task in a fast-paced environment, with flesibility and strength to navigate through crises

Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

  • Requires excellent problem solving ability and the skill to present complex issues in oral and written form.
  • Familiarity with objectives and processes across multi-disciplinary functions involved in drug development, registration and quality (GxPs).

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / experience

  • Degree in Pharmaceutics, Chemistry Chemical Engineering, or closely related field is desired.
  • Minimum 3 years’ experience in the Pharmaceutical Industry, or relevant Regulatory environment. 1- 2 years experience in technical writing and/or document processing for electronic submissions or similar.
  • Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throughout out the development lifecycle is desired.
  • Experience with, ISI Writer, MS Word®, Adobe Acrobat®, EDMS (documentum), and other publishing tools is required

Skills

  • Working knowledge of current regulations
  • Familiarity with CTD format and content of regulatory filings
  • Strong IT skills
  • Demonstrates strong skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

Behaviors

  • Active promoter of talent, knowledge sharing and collaborative spirit
  • Strong team player
  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future

Locations

Lexington, MA

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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