Synergy Bioscience is a contract research, development, manufacturing, testing, and consulting organization serving pharmaceutical, biopharmaceutical, and medical device companies across the product lifecycle. From early…
Skills: Office Administration, Records Management, Confidentiality, Microsoft Outlook, Microsoft Excel
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Full-time
Posted 14d ago
~40 hrs/week
Responsibilities
The role focuses on maintaining office records, filing systems, and confidential documentation to ensure smooth day-to-day operations. It involves coordinating communication between internal teams, external vendors, and office leadership.
Requirements
Candidates must have 5 years of mid-level administrative experience and proficiency in Microsoft Office and document management systems. Experience in a regulated life sciences environment is considered a plus.
Full job description
Synergy Bioscience is a contract research, development, manufacturing, testing, and consulting organization serving pharmaceutical, biopharmaceutical, and medical device companies across the product lifecycle. From early development through commercialization, the company supports complex, highly documented work that depends on strong coordination, accuracy, and dependable administrative support.
As an Administrative Assistant, you will help keep day-to-day operations organized, responsive, and running smoothly. This role is central to maintaining efficient administrative processes, supporting communication across teams, and ensuring important information and documentation are handled with care in a fast-moving environment.
Responsibilities
Maintain office records, filing systems, and confidential administrative documentation.
Coordinate cross-functional communication and support day-to-day office operations.
Support office leadership and work closely with internal teams, external contacts, vendors, and service providers.
Handle sensitive information with discretion and professionalism.
5 years of mid-level administrative support experience.
Experience handling confidential information with discretion and professionalism.
Experience supporting multiple priorities and meeting deadlines in a fast-paced environment.
Strong organizational skills, including experience managing records and administrative workflows.
Proficiency with Microsoft Office, including Outlook and Excel, along with experience using document management systems.
Strong written and verbal communication skills with internal teams and external contacts, and experience supporting office leadership, cross-functional teams, clients, vendors, or service providers.
Eligibility to work in the United States.
Prior experience in a regulated life sciences setting, such as pharmaceuticals, biopharma, medical devices, or quality-controlled documentation environments, is a plus.
Peggy J. Berry, MBA, RAC, is the Principal Consultant at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs, and project management topics.
Synergy's team provides expert consulting services to help clients plan, execute, and manage their regulatory strategy and pharmaceutical development. Whether you need expert assistance drafting and reviewing submissions or evaluating audit readiness, Synergy's experts will deliver optimal support. Staff training is the most important internal factor relating to a company's efficiency and success. At Synergy, all of our instructors work in the pharmaceutical development and regulatory affairs industry, so they have faced the same obstacles that your staff members will and can provide the practical insight needed for regulatory success.
-CONSULTING
Regulatory Strategy
Submission Preparation (IND, CTA, NDA, CTD, DMF, MAA, etc.)
Audit Readiness (GMP, GCP)
Promotional Materials Review
Job Descriptions
SOPs
-TRAINING
CTD/eCTD content and preparation
Regulatory strategy development
FDA meeting request, preparation, conduct & follow-up
EU meeting requests, preparation, conduct & follow-up
GCP audit preparation
GMP audit preparation
Annual GCP training
Annual GMP training
SOP development
Clinical monitoring
Clinical development (all phases)
Drug development
ANDA requirements
Regulatory leadership & development
Regulatory department management
Risk assessment and mitigation
Safety requirements
Clinical project management
Promotional materials compliance
Global regulatory agency meetings
Technical writing
Offices: 521 Andria Ave, Hillsborough, New Jersey 08844, US
pharmaceutical development consultingbasicadvanced and premium mentoringand pharmaceutical development and regulatory affairs training
Peggy J. Berry, MBA, RAC, is the Principal Consultant at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs, and project management topics.
Synergy's team provides expert consulting services to help clients plan, execute, and manage their regulatory strategy and pharmaceutical development. Whether you need expert assistance drafting and reviewing submissions or evaluating audit readiness, Synergy's experts will deliver optimal support. Staff training is the most important internal factor relating to a company's efficiency and success. At Synergy, all of our instructors work in the pharmaceutical development and regulatory affairs industry, so they have faced the same obstacles that your staff members will and can provide the practical insight needed for regulatory success.
-CONSULTING
Regulatory Strategy
Submission Preparation (IND, CTA, NDA, CTD, DMF, MAA, etc.)
Audit Readiness (GMP, GCP)
Promotional Materials Review
Job Descriptions
SOPs
-TRAINING
CTD/eCTD content and preparation
Regulatory strategy development
FDA meeting request, preparation, conduct & follow-up
EU meeting requests, preparation, conduct & follow-up
GCP audit preparation
GMP audit preparation
Annual GCP training
Annual GMP training
SOP development
Clinical monitoring
Clinical development (all phases)
Drug development
ANDA requirements
Regulatory leadership & development
Regulatory department management
Risk assessment and mitigation
Safety requirements
Clinical project management
Promotional materials compliance
Global regulatory agency meetings
Technical writing
Offices: 521 Andria Ave, Hillsborough, New Jersey 08844, US
pharmaceutical development consultingbasicadvanced and premium mentoringand pharmaceutical development and regulatory affairs training