Biotechnology, Pharmaceutical, Gene Therapy & Biologics

Whether Biotechnology, Gene Therapy or Pharmaceutical, Beacon Hill has a team focused on helping you hit your goals and objectives. From Clinical Operations, Scientific/Pre-Clinical, Bio-Manufacturing, Medical Writing and more, Beacon Hill delivers qualified candidates that fit your objectives and company culture across 50 states in a timely manner.

Clinical Operations

From start-up to close-out, Beacon Hill has the clinical operations resources,  across a broad range of therapeutic areas and all phases of development, to provide proper planning, conduct, patient safety, and data quality. From Clinical Trial Associates Clinical Study Managers, Site Monitoring, Study Management, Clinical Research Associates and more, Beacon Hill has the resources to help you meet your goals. See the positions we are currently hiring for in Clinical Operations.

Scientific/Pre-Clinical

Beacon Hill has the resources with expertise to help you cover the gamut of pre-clinical and R&D needs. From QA, QC, Chemistry, Biology, Pharmacology, PK/PD, Toxicology and more, Beacon Hill is here to help you move the drug development process forward. See the positions we are currently hiring for in Scientific.

Project Management

Beacon Hill has resources with the expertise to manage projects across many therapeutic areas.  From Global, US, Cross-Functional and more, our resources help guide you through the clinical development process. See the positions we are currently hiring for in Project Management.

Regulatory Affairs

Beacon Hill provides global regulatory affairs services across all stages of the drug and device development life cycle. From Operations/Submissions, Strategy, Medical Writing or CMC, Beacon Hill has the resources with the expertise to help. See the positions we are currently hiring for in Regulatory Affairs.

  • Strategy Development and Implementation
  • Subject Matter Expertise
  • eCTD Publishing, All Modules
  • Document Management and Archiving
  • Global Submission Development
  • Chemistry, Manufacturing, and Controls subject matter experts
  • Technical or Strategic

Bio-Manufacturing

Beacon Hill has the Bio-Manufacturing resources to help companies produce their commercially important Biomaterials. From Cell Bioprocessing to Upstream & Downstream Bioprocessing, Beacon Hill can help you achieve your goals more efficiently. See the positions we are currently hiring for in Bio-Manufacturing.

  • Cell Processing
  • Upstream & Downstream Bioprocessing
  • Manufacturing Operations
  • Supply Chain
  • Engineering & Facilities
  • Technical Operations & MS&T
     

PV/Drug Safety

Beacon Hill provides a comprehensive solution to our clients’ Pharmacovigilance (PV) departments. From PV MDs to Drug Safety Associates, staff augmentation to project based assignments, our resources ensure that all of our clients’ PV needs are met. See the positions we are currently hiring for in Pharmacovigilance and Drug Safety.

PV Operations

  • Medical Coding (MedDRA, WHO Drug)
  • Case Processing: Data Entry, Triaging, Coding, Narrative Writing, etc. for Clinical and Post Marketing
  • Scientific Literature Review

Physician Level Services

  • Medical Case Review
  • Aggregate Data Review
  • Risk Management Development and Oversight
  • Safety Signal Detection
  • Submission Writing

PV Information

  • Customization of reports
  • Database subject matter experts (Clintrace, Argus, ARISg, RAVE)
  • PV compliance and quality assurance
  • Auditing of PV agreements, internal PV departments, licensing partners, PV vendors, etc.
  • Internal tracking of departmental PV Compliance
     

Quality, Validation

Beacon Hill has the Quality Assurance resources to ensure compliance across all phases of the drug development life cycle. From establishing Clinical Quality, Quality Systems and Quality Management Plans to site and vendor audits, Beacon Hill has the expertise to help you handle all of your Quality needs. See the positions we are currently hiring for in Quality & Compliance.

  • Mock Inspections/Site Readiness
  • GxP Audits: Routine, For Cause, Pre Approval Inspection
  • QA Subject Matter Experts
  • Developing, Implementing, and Overseeing Quality Systems
  • Quality Management Plan Development and Implementation
  • Document Control: Review, Writing and Template Development
  • Corrective and Preventative Action Plans: Development, Implementation, and Close Out
  • Regulatory Response Preparation and Review (483 Letters)
  • SOP Development and Review
  • Validation
  • Internal and External GxP Auditing of Sites to include:  Manufacturing Facilities, CROs, Investigators, Monitors, Suppliers, Vendors, Contract Laboratories, QC Laboratories, Central, Specialty, and Analytical Laboratories, Licensing Partners and Agreements, Internal Departmental Audits, etc.

Medical Writing

Beacon Hill has teams of Medical Writers that can augment our clients’ existing staff or outsource entire documents for deliverable-based writing assignments. With a diverse set of specialties, our writers have experience with all types of projects. See the positions we are currently hiring for in Medical Writing.

  • Clinical, Non Clinical, Regulatory, and Safety Writing
  • Contributing to all types of submissions: IND, NDA, BLA, MAA
  • Types of documents our Medical Writers work on: CERs, Protocols, ICFs, CSRs, CDPs, IBs, PILs, ARs, Safety Narratives, PSURs, DSURs, PBRERs, and more

Medical Affairs

Beacon Hill has the medical affairs resources that can provide expertise at all stages of product development in the ever-increasing complex drug development process. From Medical Directors, MSLs, Medical Information to Project Managers, Beacon Hill has the resources to help you move forward. See the positions we are currently hiring for in Medical Affairs.

Business Operations

Beacon Hill has the business operations expertise to help you with the complex drug development process. From Clinical Contracts Management, Clinical Vendor Management, Clinical outsourcing to Strategic Operations and more, our resources help guide you move your projects forward. See the positions we are currently hiring for in Business Operations.

Biometrics

Beacon Hill has the biometrics resources to help you design, collect, analyze, convert and report your clinical trial data to the regulatory agencies. Whether Biostatisticians, Clinical Programmers or Clinical Data Managers, our team will help you with the right resource to fit your needs. See the positions we are currently hiring for in Biometrics.

  • Beacon Hill Life Sciences Staffing  

    From staff augmentation to project/business specific staffing solutions, Beacon Hill Life Sciences Staffing delivers contract, contract-to-hire, and direct-hire/executive services to companies across the United States.

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  • Beacon Hill Life Sciences Statement of Work (SOW) Solutions 

    Our team partners with your organization to perform detailed and objective assessments and define and execute upon a strategic plan.

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