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$75 hourly
Tatiana M.
- 5.0/5
- (13 jobs)
I help biotech startups, pharma companies, and research sites navigate complex regulatory landscapes to ensure successful IRB approvals, FDA submissions, and clinical trial execution. With 14+ years of experience in clinical research, regulatory affairs, and medical affairs, I have worked across drug, device, biologic, and diagnostics trials from early-phase development to post-market studies. As an independent consultant, I offer high-level expertise without the overhead of a full-time team, ensuring that your clinical and regulatory strategy aligns with long-term commercial success. SERVICES I OFFER CLINICAL RESEARCH & PROTOCOL DEVELOPMENT 🔹Clinical trial protocol writing & development (Phase I–III, Investigator-Initiated Trials, Pilot Studies, IVD, Diagnostics, Medical Device Trials) 🔹 Case Report Forms (CRFs) and electronic data capture (EDC) setup 🔹 Clinical research study design & feasibility assessments 🔹 Grant writing FDA SUBMISSION & REGULATORY COMPLIANCE 🔹 IND, IDE, Pre-IND, and Type B Meeting preparation 🔹 FDA submission document review & compliance strategy 🔹 21 CFR, ICH-GCP, and regulatory compliance consulting IRB SUBMISSION & ETHICS COMPLIANCE 🔹 IRB applications, protocol amendments, and informed consent development 🔹 Good Clinical Practice (GCP) compliance & site training 🔹 Investigator-Initiated Trial (IIT) regulatory support CLINICAL TRIAL CONSULTING & SITE STARTUP 🔹 Research site setup, SOP development, and investigator training 🔹 Clinical trial operations, site selection, and study feasibility 🔹 Medical monitoring & adverse event (AE/SAE) reporting guidance MEDICAL WRITING & DATA ANALYSIS 🔹 Clinical Study Reports (CSRs) & Investigator Brochures (IBs) 🔹 Real-World Evidence (RWE) & data interpretation 🔹 Systematic literature reviews & scientific writing Let’s connect! If you need an expert in clinical research protocol development, clinical trial consulting, or FDA submissions, let’s set up a consultation. 🔍 SKILLS & SERVICES Clinical Research, Clinical Trial Consultant, Clinical Research Consultant, Regulatory Consultant, FDA Submission, IRB Submission, Clinical Trial Protocol Writing, IND Application, IDE Submission, Pre-IND Meetings, Type B Meetings, 510(k) Submission, Good Clinical Practice (GCP), Clinical Study Design, Protocol Development, Investigator-Initiated Trials (IITs), Medical Writing, Case Report Forms (CRFs), Electronic Data Capture (EDC), Clinical Research SOPs, Regulatory Compliance, Biotech Regulatory Strategy, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Clinical Research Site Startup, Adverse Event (AE/SAE) Reporting, Systematic Literature Reviews, Medical Device Clinical Trials, FDA Regulatory Consulting, Grant Writing (SBIR, NIH)

Biotechnology
Grant Objectives & Methodology
Grant Proposal
Business Consulting
Operational Plan
Strategy
Biotechnology Regulation
Project Management
Clinical Trial Management System
Clinical Trial
Qualitative Research
Medical Editing
Clinical Systems CTMS
Science & Medicine
$45 hourly
Tarryn O.
- 5.0/5
- (0 jobs)
I am a biomedical engineer who graduated from the University of Pittsburgh in April 2024. I am interested in designing medical products and pharmaceuticals to make a difference in people's lives and help provide a better quality and length of life.

Biotechnology
Mechanical Design
Design & Usability Research
Communications
Office 365
$50 hourly
Stacey M.
- 0.0/5
- (0 jobs)
PROFILE Enthusiastic and ambitious life science industry professional seeking a challenging new role as a distinctive consultant supporting highly specialized technologies. Recognized ability to utilize knowledge of the medical research industry and life science technological workflow to understand customer’s dynamic needs. Proclivity to identify market trends including comprehensive knowledge of competitive landscape. Eager to proactively support and facilitate the success of associates, and work in a team environment to surpass set goals.

Biotechnology
Research Methods
Training & Development
Customer Service
Active Listening
Academic Research
Marketing Collateral Development
Customer Development
Pharmaceutical Industry
Life Science
Technical Writing
Market Research
Sales & Marketing
Lead Generation
$200 hourly
Jay D.
- 0.0/5
- (0 jobs)
A dedicated and experienced professional with approximately 22 years in the fields of devices, pharmaceuticals, biologics, and diagnostic products. Expertise in global regulatory affairs, including New Product Development and CMC, as well as GxP guidelines, validations, specification development, risk analysis, and mitigation. Skilled in auditing supplier and quality systems, product development, and resolving investigations. Employs diverse strategies to effectively address complex challenges. Communicates directly yet professionally, adept at prioritizing and managing multiple projects through various project management tools. Committed to quality and compliance, with a focus on continuous improvement with proactive approach to acquiring new skills. A self-motivated individual that ensures timely completion of projects without sacrificing quality. Collaborative and capable of fostering positive relationships across functional areas to achieve swift results. JDLC Consulting - Services Offered: -------------------------------------------- Regulatory strategy and management throughout the product lifecycle o Gap Assessment of development initiatives, documentation, and interactions with regulatory bodies. o Engagement with agencies: preparation, communication, and facilitation of meetings (including Pre-IND Meeting Requests/Briefing Packages and Type B and Type C Meeting Requests/Briefing Packages). o Development of Investigational Brochures to support INDs and CTAs. o Review, preparation, and negotiation of labeling with regulatory authorities. o Evaluation of global change control for regulatory impact. o Formulation of Global Regulatory Strategies for post-approval modifications. o Offers guidance and support for obtaining Orphan Drug Designation. Regulatory dossier compilation - authoring and preparation o Detailed submission strategies to assist in the creation and assembly of dossiers. o Development and evaluation of Common Technical Documents. o Management of post-approval lifecycle submissions, including BLA/NDA annual reports, IND Annual Reports/DSUR, Orphan Drug Annual Reports, supplements, safety reports, labeling supplements, post-approval commitments, line extensions, site transfers, and manufacturing scale-ups. Regulatory Operations o Development of regulatory processes and training programs for personnel to enhance efficiency and ensure compliance. o Creation of high-level overview of drug development plans/strategies as well as overviews of the IND Process, CTA process, CTN process, NDA/BLA process, MAA process. o Drafting and evaluation of Regulatory Standard Operating Procedures (SOPs), work instructions, and job aids. o Creation of eCTD templates. o Formatting and hyperlinking of submission documentation.

Biotechnology
Good Manufacturing Practice
Quality Assurance
Quality Control
Label Compliance
Biotechnology Regulation
Risk Assessment
Review
Writing
Pharmaceutical Industry
Pharmaceuticals
Drug Regulation
Strategy
Regulatory Intelligence
Regulatory Compliance
$35 hourly
Rama Sashank M.
- 0.0/5
- (1 job)
HIGHLIGHTS Startup & Industry  Lead scientific efforts as Director of R&D at Great Lakes Neuroscience, Inc. by strategizing and acquiring license to IP from the NIH to develop a peptide therapeutic for orphan neurodegenerative diseases.  Acted as the liaison between the science and business teams and raised $320k in seed funds; developed a low-risk investment strategy by introducing several go-no-go decision points based on incoming results from preclinical studies.  Technical consulting (freelance) for several startup and mid-size companies in the US to perform scientific due-diligence, IP scoping, and business development by writing pitch decks, websites, and sustainable budgets. Academic  Received a total of $2.5m in funding via grants from the Department of Defense over the last 5 years to perform research on determining mechanical and material properties of human tissues with emphasis on tissue transitions.  Extensive publication and peer review record in several international journals and editorial experience through editorship and involvement in advisory and topic boards for journals and publishing groups.  One of the principal contributors to the development of MuscleX Diffraction Imaging – an X-ray diffraction data analysis suite developed by the Biophysics Collaborative Access Team (BioCAT) at the at Argonne National Laboratory.

Biotechnology
Research Methods
Information Analysis
Business Development
Product Development
Medical Editing
Budget Proposal
Medical Writing
Investment Research
Business Plan
Medical Imaging
Communications
Biology
Analytical Presentation
Data Analysis
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