Description:We are pleased to be recruiting for a Legal Counsel at mdgroup. This exciting opportunity is a fully remote role and the candidate will be based in the East Coast of the US.
The successful candidate will be an experienced Legal Counsel with exposure to the Pharmaceutical/life sciences industry.
About Your New Company:
mdgroup is an independent global organisation, and we pride ourselves in facilitating remarkable patient experiences for individuals and their caregivers at every stage of the clinical trial journey. Now in our 20th year, we have Headquarters in the UK (Bracknell), EU (Dublin) and USA (Raleigh-Durham), with offices in Singapore, Hong Kong, France, Germany, The Netherlands and San Francisco.
Over the past few years we have grown significantly, and our growth trajectory continues to be extremely positive. We are now looking for more people to join the mdfamily, so if you enjoy working in a fast-paced, rapidly evolving environment, we'd love to talk to you.
The Main Purpose of Your Role;
To provide clear and practical legal and regulatory advice to mdgroup, ensuring that the advice and processes are a route to achieving desired outcomes.
We require 10 plus years of experience as a practicing attorney with significant regulatory experience in the clinical space and experience in the following areas is a plus: litigation, privacy, and labor & employment. Law firm experience a plus.
Your Key Responsibilities;
- To provide legal and regulatory advice to mdgroup, its Executive team and the wider business on any area of law and procedure relevant to mdgroup's activities
- To manage outside counsel, as applicable, which includes preparation of legal briefs, the selection, preparation and management of the legal budget and providing instructions to outside counsel
- To support the implementation of the legal and regulatory requirements by providing inputs on the appropriate policies and procedures that need implemented / updated
- Provide training on legal and regulatory requirements as required
- To assist with the management of risks and strategy of mdgroup from a legal and regulatory standpoint.
- To act as mdgroup's legal advisor in its dealings with third parties
- To support the Data Protection Office with privacy advice
Legal and Regulatory Compliance
- To provide legal and regulatory advice to mdgroup various stakeholders, including human resources, finance, corporate, privacy, clinical, contracts, quality, and procurement departments. Working knowledge of intellectual property helpful.
- To support audits, quality incidents and corrective and preventative action plans (CAPAs).
- To develop fifty state surveys and other resources that incorporate legal and regulatory advice to be used by various stakeholders to manage compliance obligations
- To contribute to the creation and updates of applicable policies, processes and training with the Quality team and other operational teams
- To represent mdgroup in any legal disputes and investigations, including coordination of defense with insurance carriers.
- To monitor updates in the legal and regulatory landscapes and provide support to incorporate such updates at the organisation level
- To design and provide training awareness program to further support the adherence by the members of staff and the organisation
Managing outside counsel:
Contribute to the selection, appointment, management of outside counsel globally to provide expert support regarding a broad range of legal matters in various jurisdictions
Escalation and legal support to contracts:
- Provide ad hoc support to the client contracts and procurement departments
- Develop and update company templates, including Master Service Agreement templates, Supplier Framework Agreement Templates, SAAS agreements, including SLAs and Support Agreements, Collaboration Agreements. Site Agreement, and Business Associate Agreements.
- Handle escalations on contracting matters as appropriate (e.g. providing alternative contracting language and advising regarding indemnity, liability, and insurance)
- Assist with development of playbooks and other contracting tools
Global Data Protection:
- Informing and advising mdgroup and its employees carrying out processing operations about mdgroup's obligations under data protection laws globally, including HIPAA, GDPR, and other country specific privacy laws;
- On request, advising in connection with the data protection impact assessments and transfer impact assessments, as appropriate
- Supporting the Data Privacy Office i.e., communications with Clients and supervisory authorities; and
- Support the Data Privacy Office's implementation and roll-out of the global privacy strategy of the organization, taking into account the interplay between clinical trials regulations and privacy legislation
- Provide advice and counsel to the Data Privacy Office regarding implementation of global privacy requirements
- Review informed consent forms (ICFs) and data collection form (DCFs) to ensure they are compliant with country specific privacy requirements
- Maintaining and updating data privacy agreement (DPA) templates, standard contractual clauses (SCCs), and other privacy documents
The successful candidate will receive a competitive benefits package in return:
- 25 days paid time off every year
- We look after our mdgroup family by offering an employee referral program
- A managed benefit program (including medical, vision, dental, life and disability plans)
- And much more!