Associate Legal Counsel
Harvest Integrated Research Organization (HiRO) is a globally-oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our Team Members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide.
Job Title: Associate Legal Counsel
Location: US, Home based
Work Type: Remote, with occasional travel
Job Summary: We are seeking an experienced Associate Legal Counsel to join our dynamic team. The position provides legal support at company level and to various departments and functions including HR & employment law support, developing and updating contract templates, developing and reviewing company policies to ensure compliance, and serving as the point of contact for outside counsel. The primary focus for the role is for the US region but may also need to support other regions as needed. This position requires the ability to perform key responsibilities independently and the ability to work collaboratively in a global environment.
Key Responsibilities:
Corporate legal:
- HR & employment law support to include multiple state employer guidance/compliance, immigration law and visa support, employment offer compliance, handbook compliance, and risk mitigation.
- Corporate policies including general policies code of conduct, data policies, non-solicits, etc.
- Commercial, vendor contract review;
- IP including trademark application, discussion on IP polices; legal queries on data privacy
- Tracking of all signed agreements and legal documents
- Assisting on matters of corporate housekeeping and compliance such as POA, shareholder meeting, shareholding structure.
- Advice on US law related issues and any ad hoc requests
Business support:
- Development and updating contract templates, negotiation tools, fallback documents, including company level NDA/CDA(for sponsor/client and vendor), sponsor contracts, partner contracts, vendor contracts.
- Coordinate with all functions on winning business opportunity and mitigate risks.
- Provide trainings to commercial team and BO team on MSA, negotiation on the contract from legal perspective.
- Advise the business on regulatory, privacy, antitrust, advertising/promotional, commercial, compliance, improper payment matters
- Lead or participate the discussion to align the contracting and payment strategy
- Lifecycle supervision and management on all contracts including termination, expiration, amendment, renewal.
- Other ad hoc requests
Site contract support:
- Provide legal support in assigned project and be responsible for legal escalation to sponsor
- Legal support on ICF, POA/LOA, LRA and ancillary legal documents
- Provide legal support to Lead Clinical Contract Specialist on site contract negotiation
- Work together with CRA on partner site contract strategy
- Provide site contract training sessions from time to time internally and externally.
- Other ad hoc requests
Qualifications:
- Minimum of 3 years of progressive experience as practiced lawyer in corporate law and/or employment law and/or immigration law, or in-house.
- Experience as in house counsel is strongly preferred.
- Knowledge of CRO related laws and regulation GCP/ICH guidelines and other applicable regulatory requirement is preferred.
- Excellent communication, presentation, interpersonal, teamwork, both written and spoken, with an ability to inform, influence, convince, and persuade.
- Strong time management, technical and organizational skills.
- Ability to work independently and within a team environment.
- Must demonstrate good computer skills and be able to embrace new technologies.
- JD or LL.M from an accredited law