Practice Areas

At Beacon Hill Pharma, our teams of Clinical Study Managers and Clinical Research Associates are committed to quality and compliance, bringing in-depth experience across a broad range of therapeutic areas and all phases of development.

If your organization needs assistance staffing any of the follow areas, or you are a practitioner within Clinical Research, contact our seasoned industry experts to learn more about our services.

• Clinical Development and Study Design
• Protocol Development
• CRO/Vendor Identification, Selection and Management
• Study Activity Management
• Site Monitoring: Site initiation, Site Management and Site Close-out

Beacon Hill Pharma 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

From the beginning stages of research and development to manufacturing, Beacon Hill Life Sciences supports the technical needs of our clients by providing the top talent in the market. By focusing solely on R&D and Quality our team is able to effectively service industries including but not limited to Chemical, Agriculture, Food, Beverage, Distilleries, Breweries, Flavors, and Personal Care Products.

From a Sr. Level Formulation Chemist to a manufacturing Quality Control Technician we are here to deliver with long term and short term placements.

Skill Sets

• Chemist
• Biologist
• Microbiologist
• Scientist 
• Quality Assurance Technician
• Quality Control Technician 
• R&D Lab Technician
• Food Scientist
• Food Technologist
• Biochemical Engineer
• Chemical Engineer
• Validation Engineer 
• Regulatory Affairs Specialist

Beacon Hill Pharma has a team 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.

Nonclinical:

• CMC/Quality and Quality Summary Sections of Submissions
• Nonclinical Overview and Nonclinical Study Reports

Clinical:

• Clinical Study Reports (CSRs) and Clinical Summary and Overview

Safety Documents:

• Integrated Summaries of Safety
• Integrated Summaries of Efficacy
• Safety Narratives
• Annual and Periodic Safety Reports
• Responses to Regulatory Authorities

Other:

• Technical Writing
• Publications and White Papers

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.

Regulatory Affairs

• Strategy Development and Implementation
• Subject Matter Expertise

Operations and Submissions

• eCTD Publishing, All Modules
• Document Management and Archiving
• Global Submission Development

Medical Writing

• Clinical, Non Clinical, Regulatory, and Safety Writing
• Contributing to all types of submissions: IND, NDA, BLA, MAA

CMC

• Chemistry, Manufacturing, and Controls subject matter experts
• Technical or Strategic

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

Service offerings:

• 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.

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.

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 has the business operations expertise to help you with the complex drug development process. From Clinical Contracts Management 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.

From start-up to close-out, Beacon Hill has the clinical operations resources to provide proper planning, conduct, patient safety, and data quality. From Clinical Trial Associates Clinical Study Managers, 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.

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 to Project Managers, Beacon Hill has the resources to help you move forward. See the positions we are currently hiring for in Medical Affairs.

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.

Beacon Hill has the resources with expertise to help you cover the gamet of pre-clinical and R&D needs. From QA, Chemistry, Biology, Pharmacology 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.