• Legal Consultant Regulatory

    Are you the lawyer who wants to work in a legal environment with an international pharmaceutical company?

    Functieomschrijving

    Purpose of the Position

    With guidance from Executive Director, Legal Regulatory Lead, and Senior Director, Legal Regulatory Counsel:
    • Receive and triage contracting and other legal queries and escalations from Medical & Development (M&D) functions in Leiden, NL and Chertsey, UK, including Pharmacovigilance and Medical Affairs, as well as Procurement;
    • Deal with routine contract escalations and document reviews including pharmacovigilance agreements, legal agreements relating to M&D functions and review of quality plans and corrective action plans;
    • Provide support to Senior Director, Legal Regulatory Counsel and other members of the Legal team by undertaking legal research on subjects relevant to the Regulatory Legal team;
    • Manage legal aspects of M&D projects including monitoring timelines and deliverables;
    • Manage Regulatory Legal team projects including drafting and implementation of guidelines, policies and procedures.

    Core Tasks
    • Contracts and document reviews
      • Serve as contact person for standard / routine legal transactions and queries for business stakeholders including M&D functions in Leiden and Chertsey including Procurement;
      • Draft, review, revise and manage (as necessary) routine agreements, such as pharmacovigilance agreements, legal agreements relating to M&D functions and Procurement as well as other legal documents.
    • Legal queries
      • Receive and triage legal queries from business stakeholders according to level of risk and relevant lawyer/team within Legal;
      • Refer non-standard / high risk queries to Senior Director, Legal Regulatory Counsel or other Legal colleague and manage/track completion, following up when necessary;
      • Advise business stakeholders on routine / low risk legal queries including conducting review of documents, presentations and (draft) communications with third parties.
    • Legal Support
      • Undertake legal support including legal research and proof reading;
      • Review, draft and manage Legal team governance documents, including guidance notes, policies and procedures for business stakeholders.
    • Projects
      • Manage legal aspects of M&D, Procurement and other business stakeholder projects, overseeing timelines and deliverables;
      • Manage Legal team projects, setting and overseeing timelines and deliverables.
    • Administrative / miscellaneous tasks including
      • Prepare, update and review legal department presentations and training materials;
      • Draft supporting documentation for meetings e.g. meeting minutes or meeting agenda.

    Functie-eisen

    • Qualified lawyer or experienced paralegal with a degree in law  or equivalent experience;
    • Proven track record of legal / paralegal work, preferably in the pharmaceuticals/life sciences sector;
    • Experience in drafting and negotiating general commercial agreements including service agreements, confidentiality agreements;
    • Track-record of leading planning process with excellent organisational and collaboration skills;
    • Proven ability to influence, (appropriately) challenge and engage diverse stakeholders;
    • Collegiate, professional approach and an ability to work as part of a team or independently as required;
    • Proven legal analytical and drafting skills;
    • Fluent in written and verbal business English.

    Competencies
    • Customer Focus
      • Acts to support a culture where everything is done to enhance value to patients.  Intentional about meeting/exceeding customer expectations;
    • Strategic Orientation
      • Understands how personal/team objectives contribute to Astellas’ strategy and functional goals;
    • Innovation & Change
      • Identifies improvements and generates new ideas, methods or solutions.   Positively embraces change;
    • Results Orientation
      • Ability to work autonomously and make evidence-based decisions: judgement to know when to seek guidance or escalate;
    • Communication & Collaboration
      • Collaborates: values others views and perspective.  Able to challenge respectfully and propose alternative solutions;
    • Developing & Inspiring
      • Proactively shares knowledge and best practice and encourages others to develop;
    • Working as one of the team
      • Takes personal ownership and acts as a role model of ethics and compliance treating everyone with respect;

    Bedrijfsinformatie

    The company is an international pharmaceutical with more than 15,000 employees worldwide. The organization has an extremely solid reputation as a research-oriented company and a leading position within the pharmaceutical industry. The most important goal of the organization is the development, production and marketing of ethical pharmaceuticals.

    More information?

    For more information you can contact Geert-Jan Reijmer (Business Consultant) via +316 22 41 83 24.

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