2187- Associate/Principal Regulatory - Pharmacovigilance Writer

  • Veröffentlicht am 14.01.2022
  • Festanstellung
  • Lörrach

Einleitung

Responsibilities:

  • Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
  • Lead a project team, actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
  • Serve as liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval/agreement from regulatory authorities for all document types that Synchrogenix writes
  • Author documents per client specifications, templates, style guides, and other guidance documents
  • Author documents per regulatory authority guidelines and requirements
  • Act as client advisor and proactive consultant to collaborate and anticipate the needs of the client based on the relationship and knowledge while looking for new business opportunities 
  • Take ownership of entire deliverable that include multiple writers
  • Manage budget for all types of projects, liaise with finance and mentor others in fiscal responsibility and outcomes at the project level
  • Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus
  • Maintain collaborative, proactive, and effective communication with both client and internal teams
  • Lead project-related meetings and teleconferences and coach others in same
  • Provide coaching to junior staff for all documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
  • Education, Experience, Training, and Knowledge:

  • Bachelor’s degree (minimum)
  • 8 to 10+ years of regulatory writing experience in pharmacovigilance related documentation (e.g., PSURs, PBRERs, DSURs, EU RMPs and Patient Narratives) 
  • Understands regulatory requirements for different phases of development and different regulatory pathways
  • Knowledge of global health authority requirements
  • Collective experience writing and leading a range of documents in their entirety (e.g. study and submission level, pharmacovigilance)
  • Strong understanding of the document creation process and of the drug development lifecycle
  • Skills & Abilities:

  • Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques 
  • Able to synthesize data across multiple data sources and documents to create summary reports
  • Practice blameless problem solving, effectively managing all crisis communications, managing risks, and realizing business opportunities
  • Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
  • Ability to lead submission-level sections, taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
  • Ability to lead sub-teams for deliverables (e.g., pharmacovigilance documents: PSURs, PBRERs, DSURs, EU RMPs and Patient Narratives), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
  • Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
  • Ability to identify potential problems, promptly tackling those problems, particularly in sensitive or high-pressure situations
  • Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization
  • Locations: Fully home-based/remote in US, Canada and Europe- UK, Germany, France and Netherlands

    Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

    #LI-HM

    Standort

    Certara, Lörrach
    https://www.absolventa.de/stellenangebote/5104591-b-2187-associate-principal-regulatory-pharmacovigilance-writer
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    Gesundheit
    Pharma
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