Legal Consultant RegulatoryAre you the lawyer who wants to work in a legal environment with an international pharmaceutical company?
FunctieomschrijvingPurpose 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.
- 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.
- 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.
- 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.
- 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;
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.
For more information you can contact Geert-Jan Reijmer (Business Consultant) via +316 22 41 83 24.