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Biologics Consulting is regulatory and product development consulting firm specializing in biologics, pharmaceuticals, and medical devices.

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Biologics Consulting is a leading full-service regulatory and product development consulting firm specializing in biologics, pharmaceuticals, and medical devices. With its establishment in 1993, Biologics Consulting has become the go-to partner for both large corporations and small innovators looking to bring innovative and safe products to the market in the United States. The firm is founded on the belief that biotechnology, medical devices, and pharmaceuticals hold the potential of a better future for all. To fulfill this promise, Biologics Consulting combines innovative approaches, cutting-edge science, regulatory expertise, and a dedicated team. Over the past three decades, they have successfully supported clients worldwide in tackling nonclinical, clinical, product development, and regulatory compliance challenges. With a team of consultants and subject-matter experts with extensive industry and FDA experience, Biologics Consulting ensures a seamless integration into clients' existing product development processes and works collaboratively to provide effective solutions. Start your journey to success with Biologics Consulting today.

Biologics Consulting

Biotechnology and Pharmaceuticals

Health

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Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US. Our team of regulatory scientists, FDA consultants, and professional services staff has decades of industry and FDA experience that allows us to provide an unparalleled insider perspective for our clients.

  

OUR DIFFERENCE

The Biologics Consulting difference is all about the unique combination of regulatory expertise we have under one roof. Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client’s regulatory and product development challenges from preapproval to commercialization.

  

OUR EXPERIENCE AREAS

\- Biologics

\- Medical Devices

\- Pharmaceuticals

\- Biosimilars

  

OUR SERVICES

\- CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support.

\- SUPPORT SERVICES – Medical Writing, e-Publishing & Submissions, US Agent Services, Due Diligence

OUR CLIENTS

Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.

Fractional HRBP
---------------

The Fractional HR Business Partner will have a focus on talent acquisition as well as other HR generalist duties such as providing expertise, advice and counsel in areas including but not limited to benefits, labor and employment law, onboarding and training. This role is a key member of the team contributing to various aspects of the human resources role to ensure the effective functioning of the HR department.

### Essential Duties and Responsibilities:

*   Responsible for daily operations of the human resources department to include full-cycle payroll processing, benefits administration, HRIS administration, open enrollment, etc.
*   Development and delivery of organization-wide training
*   Streamline onboarding process to include implementation of a mentoring and development program
*   Oversight of the performance management process
*   Responsible for the full-life-cycle talent acquisition process through employee onboarding.
*   Lead the development and execution of cutting-edge recruitment approaches to ensure a diverse and dynamic candidate pipeline. Continuously monitor industry trends, best practices, and emerging tools to enhance the recruitment process.
*   Proactively identify, engage, and attract top-tier talent through various channels, including job boards, social media, networking events, and specialized industry platforms.
*   Collaborate closely with senior hiring managers, up to Executive level, to gain a deep understanding of their talent needs and work together to develop tailored recruitment strategies aligned with the company's objectives.
*   Conduct in-depth intake meetings that translate into effective candidate assessments, including interviews and skills evaluations to ensure the selection of top-tier candidates.
*   Provide timely information and/or education for all levels of the company on HR issues.
*   Develop and administer company equal employment opportunity and affirmative action programs, files EEO-1 and Vets100 annual reports. Maintain other records, reports and logs to conform to EEO regulations.

### Education:

Bachelor's or Master's degree in Human Resources, Organizational Management, Business or related field. Certifications in human resources (SHRM-SCP or SPHR) or strategic talent acquisition management will be considered a plus.

### Experience:

Minimum three (3) years of experience as HR Generalist/Talent Acquisition Specialist with significant experience in full life-cycle talent acquisition

*   Proven track record as a recruiter for varying levels of positions and preferably with some experience in the biotechnology/pharmaceutical industry.
*   Mastery in becoming a company brand ambassador and adept at building internal and external networks engaged with our company's job openings.
*   Innovative mindset with an insatiable curiosity for exploring novel recruitment techniques.
*   The HR Business Partner must possess deep business acumen; must possess a history of understanding companies and their challenges to help address the organization and talent needs.
*   Knowledge of state and federal labor laws governing human resources, benefits and payroll administration.
*   Previous hands-on experience in payroll processing
*   Proficiency in using human resources information and talent management systems (ADP, Workday, LinkedIn or PeopleSoft)
*   Demonstrated analytical thinking, problem solving, and decision-making skills. Critical thinker with success in developing innovative solutions to business issues.
*   Outstanding interpersonal and communication skills, both verbal and written.
*   Ability to listen and understand the needs of the employees, together with those of the company.
*   Ability to manage multiple, complex issues and prioritize projects concurrently.
*   Exceptional organizational skills, attention to detail, and proficiency in managing multiple tasks and priorities.
*   Knowledge and administration of online training and learning systems.

### Skills:

Proficient in Microsoft Office Suite, keyboard skills, strong documentation skills, math aptitude, diplomacy, professionalism, organization, time management, able to maintain confidentiality, ability to multi-task, able to work independently.

Director of Human Resources | 
J. D. Candidate 3L | Southern University Law Center

Sharon Darby

Director of Human Resources

Fractional HR Business Partner

Talent Acquisition

Business Manager

ABOUT
Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US.  Our team of regulatory scientists, FDA consultants, and professional services staff has decades of industry and FDA experience that allows us to provide an unparalleled insider perspective for our clients.

OUR DIFFERENCE
The Biologics Consulting difference is all about the unique combination of regulatory expertise we have under one roof.  Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client’s regulatory and product development challenges from preapproval to commercialization.

OUR EXPERIENCE AREAS
-	Biologics
-	Medical Devices
-	Pharmaceuticals
-	Biosimilars

OUR SERVICES
-	CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support. 
-	SUPPORT SERVICES – Medical Writing, e-Publishing & Submissions, US Agent Services, Due Diligence
	
OUR CLIENTS
Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.

Biologics Consulting is a leading FDA regulatory and product development consulting firm

**Fractional HRBP**

The Fractional HR Business Partner will have a focus on talent acquisition as well as other HR generalist duties such as providing expertise, advice and counsel in areas including but not limited to benefits, labor and employment law, onboarding and training. This role is a key member of the team contributing to various aspects of the human resources role to ensure the effective functioning of the HR department.

**Essential Duties and Responsibilities:**

- Responsible for daily operations of the human resources department to include full-cycle payroll processing, benefits administration, HRIS administration, open enrollment, etc.
- Development and delivery of organization-wide training
- Streamline onboarding process to include implementation of a mentoring and development program
- Oversight of the performance management process
- Responsible for the full-life-cycle talent acquisition process through employee onboarding.
- Lead the development and execution of cutting-edge recruitment approaches to ensure a diverse and dynamic candidate pipeline. Continuously monitor industry trends, best practices, and emerging tools to enhance the recruitment process.
- Proactively identify, engage, and attract top-tier talent through various channels, including job boards, social media, networking events, and specialized industry platforms.
- Collaborate closely with senior hiring managers, up to Executive level, to gain a deep understanding of their talent needs and work together to develop tailored recruitment strategies aligned with the company's objectives.
- Conduct in-depth intake meetings that translate into effective candidate assessments, including interviews and skills evaluations to ensure the selection of top-tier candidates.
- Provide timely information and/or education for all levels of the company on HR issues.
- Develop and administer company equal employment opportunity and affirmative action programs, files EEO-1 and Vets100 annual reports. Maintain other records, reports and logs to conform to EEO regulations.

**Education**
:

Bachelor’s or Master’s degree in Human Resources, Organizational Management, Business or related field. Certifications in human resources (SHRM-SCP or SPHR) or strategic talent acquisition management will be considered a plus.

**Experience:**

Minimum three (3) years of experience as HR Generalist/Talent Acquisition Specialist with significant experience in full life-cycle talent acquisition

- Proven track record as a recruiter for varying levels of positions and preferably with some experience in the biotechnology/pharmaceutical industry.
- Mastery in becoming a company brand ambassador and adept at building internal and external networks engaged with our company's job openings.
- Innovative mindset with an insatiable curiosity for exploring novel recruitment techniques.
- The HR Business Partner must possess deep business acumen; must possess a history of understanding companies and their challenges to help address the organization and talent needs.
- Knowledge of state and federal labor laws governing human resources, benefits and payroll administration.
- Previous hands-on experience in payroll processing
- Proficiency in using human resources information and talent management systems (ADP, Workday, LinkedIn or PeopleSoft)
- Demonstrated analytical thinking, problem solving, and decision-making skills. Critical thinker with success in developing innovative solutions to business issues.
- Outstanding interpersonal and communication skills, both verbal and written.
- Ability to listen and understand the needs of the employees, together with those of the company.
- Ability to manage multiple, complex issues and prioritize projects concurrently.
- Exceptional organizational skills, attention to detail, and proficiency in managing multiple tasks and priorities.
- Knowledge and administration of online training and learning systems.

**Skills:**

Proficient in Microsoft Office Suite, keyboard skills, strong documentation skills, math aptitude, diplomacy, professionalism, organization, time management, able to maintain confidentiality, ability to multi-task, able to work independently.

United States

The Fractional HR Business Partner will focus on talent acquisition and HR generalist duties, including benefits, labor law, onboarding, and training. Responsibilities include payroll processing, benefits administration, recruitment, and performance management.

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