Biopharma International Counsel - Data Privacy & Compliance

*MUST HAVE held an internal legal position (specialising in Data Privacy & Compliance) with a prestigious biotech or pharmaceutical company with notable marketed goods or worked at a top European national law firm. Product knowledge for uncommon diseases is a plus.

Being a major leader in the biopharmaceutical sector worldwide, I am working with a firm committed to transforming the way that people with uncommon illnesses are treated.

The Legal and Compliance team is looking for a motivated and experienced member to work with them in their International Region, mostly in Europe. You will provide thorough legal and compliance advice in your role as International Counsel.

You will also help with legal, and compliance matters for all the company’s development pipelines and programmes. As a member of an adaptable legal team committed to providing strong support to the company's goals, you will report to the Head of Legal for International operations, who is based in the UK.

Responsibilities

• Serving as the main point of contact for legal advice and direction on data privacy-related laws, rules, best practices, strategic planning, and decision-making procedures.
• Support the development of the company’s GDPR compliance plan, data privacy strategies, policies, and processes, and effective risk management of privacy. These measures ensure that the company’s operations comply with applicable laws and regulations.
• Assist the legal team and other departments in making sure that the business's activities and products comply with data privacy regulations. This includes managing regulatory body investigations and audits, handling data security incidents, and supervising data privacy-related concerns.
• Support the creation, implementation, and improvement of the company's compliance programme, with an emphasis on the international region. This includes creating and delivering relevant training as well as policies and procedures.
• Provide internal clients with legal advice regarding EMA/MHRA laws and regulations, fraud and abuse laws and regulations, and other pertinent laws and regulations pertaining to the creation and marketing of pharmaceutical goods in the EU and other foreign jurisdictions.
• Verify compliance with relevant laws and regulations by reviewing and offering legal advice on dealings with patients, payers, advocacy groups, and healthcare professionals.
• Give customers knowledgeable, helpful guidance and counsel regarding local country laws and EMA regulations regarding product labelling, promotional activities, and marketing strategies.
• As a reliable business partner, provide counsel to colleagues in the international area on projects, campaigns, and communications pertaining to both approved and pending market authorisation goods and indications.
• As a member of the company’s Legal, Medical, and Regulatory (LMR) Committee, evaluate and offer advice on promotional materials.
• Examine, evaluate, and offer advice on issues pertaining to market access, patient support and assistance initiatives, government coding and reimbursement, and choices on payment and coverage.
• Draft, examine, and negotiate contracts pertaining to research, clinical trials, business dealings, agreements with third parties, services, consulting, and other corporate matters.
• Work cooperatively with colleagues in legal and compliance in the US to guarantee a uniform strategy throughout the entire company.
• Identify legal and compliance risks ahead of time and collaborate with other internal stakeholders to successfully eliminate or reduce them while also supporting the strategic goals of the organisation.

Requirements

• LLM Degree.
• Admitted to the bar in at least one European nation, allowing one to practise law in Europe.
• 5+ years experience as a practicing attorney, 3+ years of expertise advising the pharmaceutical and biotech industries in Europe (internal biotech/pharmaceutical sector experience is preferred)
• Have worked with general data concerns and data privacy in a commercial setting for at least four years.
• Considerable expertise in compliance.
• The ideal applicant will have held an internal legal position with a prestigious biotech or pharmaceutical company with notable marketed goods, or they will have worked at a top European national law firm. Product knowledge for uncommon diseases is a plus.
• Comprehensive knowledge of applicable rules and regulations pertaining to the creation, promotion, and sale of pharmaceutical products as well as the present state of government enforcement, derived from extensive experience with EU and worldwide legislation and regulations governing pharmaceutical and biotech products. A benefit would be knowledge of the rules and legislation pertaining to genetic testing.
• Thorough experience reviewing and advising on international promotional materials as a member of a promotional review committee, as well as familiarity with EMA laws and local country requirements on promotional activities and marketing strategies.
• Significant expertise in the preparation, examination, and negotiation of contracts pertinent to the biotech and pharmaceutical industries, such as research, clinical, and commercial agreements.
• Practical GxP knowledge and expertise is advantageous.
• Outstanding interpersonal and written communication abilities, as well as bargaining capabilities.
• Capacity to autonomously oversee task in a hectic setting. Ability to communicate effectively with staff members at all organisational levels and offer timely, risk-appropriate, and useful legal advice to a broad range of internal clients on legal and regulatory issues.
• Proficiency in written and spoken English.

Think you're a good fit? Apply today:

Email address: gjohnstone@barringtonjames.com

Telephone: +44 1293 77 8 666