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$120 hourly
Elizabeth P.
- 5.0/5
- (56 jobs)
Over 15 years of experience with medical device and pharmaceutical regulatory compliance and quality systems. Areas of expertise include: -21 CFR 820 (Medical Device GMP) -21 CFR 211 (Pharmaceutical cGMP) -21 CFR 111 (Dietary Supplements) -ISO13485: 2016 (Medical Device Quality Systems) -Internal auditing -FDA responses/corrective actions for 483s/Warning Letters -Gap assessment and remediation -Writing and revising policies and procedures for quality system compliance -Regulatory and claim substantiation reviews of labeling and marketing materials -Design control regulatory team member -Risk assessments -Regulatory due-diligence for acquisitions -FDA preparedness training -Supplier management -Complaint management and reporting to regulatory agencies -3rd party audit responses and CAPA development -Recall coordinator -UDI implementation -California Prop65 compliance -State Board of Pharmacy licensure for manufacturers/wholesalers -NAFTA COO Certifications, VA Letters of Supply, Conflict Minerals Surveys, FDA Certificates for Foreign Governments applications -FDA Medical Device Establishment registration and Device Listings -Deviation investigation and risk assessment/mitigation -ABC (American Board for Prosthetics and Orthotics) Facility Accreditation/Medicare Supplier Accreditation (developed quality system to ensure compliance; lead audits) Proficiency in the following: -Trackwise -Salesforce -Word -Excel -Powerpoint -Access -Adobe Specializing in the development of lean, efficient and compliant solutions to address FDA and international regulatory requirements.

Pharmaceutical Industry
Project Risk Management
Vendor Management
Company Policy
Medical Device
Document Review
Document Management System
Internal Auditing
Regulatory Compliance
Procedure Manual
$75 hourly
Michael R.
- 5.0/5
- (6 jobs)
Pharmaceutical drug development leader with twenty years of management and supervisory experience. Key roles as scientist/lead on a large number of clinical trials, experience as head of group implementing imaging biomarkers in trials, former leader of clinical strategy for a public pharmaceutical company as its Chief Medical Officer, and current Chief Executive Officer of a clinical research services organization and pharmaceutical company. Expertise in clinical trial design and conduct, clinical and preclinical imaging/imaging biomarkers and their implementation in trials and studies, oncology and other disease areas/organ systems (neurology, cardiology, hematology, inflammation/fibrosis, musculoskeletal, pulmonary, and immunology), biomedical imaging instrumentation and applications, digital pathology, animal models of human disease, and pathophysiology. Experience in financing, capital raise, and investor relations for public and private pharmaceutical companies.

Pharmaceutical Industry
Scientific Research
Scientific Writing
Medical Writing
Biotechnology
Research Documentation
Research & Strategy
Research & Development
Clinical Trial
$120 hourly
Megan P.
- 5.0/5
- (5 jobs)
I'm a cosmetic chemist at Una Care Products with over half-a-decade of experience in more than 500 cosmetic & personal care products. I can help with every step to take an idea and launch it into your customer's hands. I use science to back up my work through ingredient choices, raw materials, custom formulation, reverse engineering, and even testing. My education has provided me the knowledge to analyze and create an aesthetically pleasing product. Having communication with my clients is very important, and is what makes a product successful. Una Care Products has over 50+ formulas available for private labeling and has worked on 1000+ custom formulations. We offer reverse engineering, custom, & private formulation services to our clients looking to start, or enhance, a product or brand. Una Care holds one of the lowest MOQs in the industry for filling and an even lower MOQ for scale-up services. We have experts that help with formulation, labeling, packaging, marketing, and brand development. We are growing exponentially fast, so let us help you!

Pharmaceutical Industry
Laboratory Equipment Skills
Chemistry
Product Development
Cosmetic Raw Materials
Efficiency Testing
Product Stability
Packaging Design
Cosmetic Regulation
Private Labeling & White Labeling
Manufacturing
Beauty & Personal Care
Reverse Engineering
Product Formulation
Cosmetics
$250 hourly
Peter G.
- 5.0/5
- (115 jobs)
I earned my Doctor of Medicine (MD) in 2016 from the Virginia Tech Carilion School of Medicine and after a year of internal medicine training at a major academic university, I decided to pursue my true passion of writing and research. I have since served as the lead writer for a large medical technology and communications company, spearheaded the development of extensive educational materials for several large pharmaceutical companies, and solely developed multiple high-yield USMLE and internal medicine question banks. In addition to these larger tasks, I have thoroughly enjoyed assisting students and future medical providers in developing strong personal statements and applications for medical school, residency, and fellowship. About My Work: I pride myself on providing the highest quality evidence-based medical writing available on this platform. My unique combination of medical education, research acumen, and other intangibles allow me to thrive in creating accessible content for both professionals and lay audiences alike. I am particularly adept at digesting complicated medical jargon into easy-to-read, conversational, and relatable information for the average reader. I set an exceptionally high standard for myself, and satisfaction of both my clients and their audience is paramount. If you want original content that is factual and captivating, I'd be happy to discuss your project. My Specialties: Medical or academic writing, medical editing, health content creation, manuscript development, white papers, pharma technical writing, personal statements and application assistance for medical school/residency/fellowship, and NBME/COMLEX/USMLE or basic science question writing. ------------------------------------------------------------------------------------------------ I believe my client’s experiences speak the loudest: "Peter is a superb writer and researcher. He works quickly and effectively to delivery exactly what I needed, on time. Will definitely work with Peter again! " “Peter is a hidden gem. He did an amazing job at proofreading my medical school secondary applications. He has a way of maintaining your voice while at the same time making you sound so much better. He is a man of his word and will adhere to deadlines. He is friendly and genuinely interested in making your writing sound the best that it can.” "Peter was awesome to work with - Quick to write up high quality content with detailed research to back up claims, great writing style and flexible to make major and minor changes in a flash. He quickly understood where we needed changes and made them perfectly and immediately. Looking forward to working with you again. " "Excellent job!! Far exceeded the expectations. Probably the highest quality work I had seen for some time. Great writer." “My second job with Peter, again delivered to a very high standard and within the deadline. Will definitely use again!” “Peter completed the task as requested, ahead of deadline and revised his work appropriately to the feedback given. I highly recommend Peter for medical writing. “ “Dr. Peter G. was quick to respond and easy to work with. I highly recommend his services and will definitely use him in the future when I have a similar project.” “Peter was extremely knowledgeable about the work that I needed to do and was really great about sticking to deadlines and communicating. Would highly recommend Peter for the quality of work!”

Pharmaceutical Industry
Medical Report
Science & Medicine
Copywriting
Academic Editing
Proofreading
Scientific Writing
Content Writing
Medical Editing
Education
$165 hourly
Jennifer E.
- 0.0/5
- (0 jobs)
SUMMARY My professional experience includes product strategy & management, global marketing, competitive strategy & commercial launch, building and leading high-impact teams, communicating and presenting to influence audiences large and small, collaborating with internal and external teams to deliver solutions with excellence, and successfully commercializing a first-in-class combination product - all strategically planned and executed to maximize impact and drive business growth. As a Product Marketing expert and executive with strong and diverse experience in marketing, commercial, and communications, my passion is to utilize my expertise to strategically launch innovative products and make a positive impact for patients worldwide. I have deep marketing experience and a self-starter ethic, to deliver exceptional work, on-time and within budget. My marketing experience includes key aspects: Successful Launch Experience I led the marketing, commercial strategy and execution for first combination product, enFuse ® - technology-based EMPAVELI ® Injector. The Oct 2023 FDA approval led to a rapid successful commercial launch in which patient conversion surpassed 60+% in less than 3 months in a highly competitive market. My experience also includes launch strategy for upcoming global blockbuster drug launches, with patient support programs to support business objectives. Proven Success with Brand to Reach the Patient Experience My experience includes research to survey the market, develop the patient journey, and execute digital services to support an excellent patient experience at each strategic touchpoint. Digital Transformation I have deep experience in development of digital media, strategic messaging, support services, including Apps, CRM, chats, patient support programs, videos, and experiences to collect data, analyze, and adjust course to achieve business objectives and optimal patient support. Excellence in Collaboration in Matrixed Environment My strengths are not only analytical and strategic, but also are centered on building positive relationships and a productive work culture with teams in a matrixed environment. Having developed high-performing teams, I excel at relationship development and agility in collaboration, and work well with leadership, partners, KOLs, internal matrixed Marketing, R&D, Commercial, and other internal and external groups. Agility and Innovation with Pharma and Medtech Background, I have success in collaborating with key internal and external stakeholders to drive innovation to benefit the patient and integrate strategy to exceed business goals, as well as presenting to evangelize the brand. Visit jlestepbusinessconsulting.com to learn more.

Pharmaceutical Industry
Investor Overview
Marketing Plan
Presentations
Market Research
Digital Marketing Strategy
Digital Marketing
Crisis Communications Plan
Content Marketing Strategy
Content Marketing
Leadership Skills
Strategy
Freelance Marketing
Marketing
Product Launch Plan
$100 hourly
Jacque C.
- 0.0/5
- (0 jobs)
I am deeply passionate about driving innovation and impact across various industries, particularly in pharmaceuticals and bio synthetic production, leveraging my expertise in biochemistry. I have a strong foundation in research, technical, and analytical skills as described in my CV. I’m also an extremely independent and quick study, and my experience shows my initiative to pick up new skills and pass my knowledge on to others. I’m extremely motivated by communication, mentoring, and training. During my PhD, I studied terpenoid biosynthesis. I used cryo-EM and X-ray crystallography to solve protein structures with the aim of informing commercial biosynthesis of terpenoid-based drugs in the future. This focus continued into my postdoctoral studies, where I studied polyketide biosynthesis using structural biology. Ultimately, my main focus was onboarding cryo-EM in the lab and training others, which was very fulfilling for me. My academic training ultimately led me to industry, and I am currently a biophysics investigator at GSK. I am thrilled to be leveraging my technical skills, pivoting my focus toward drug discovery. Alongside my technical research, communication remains one of my biggest motivations. I’m enthusiastic about the opportunity to engage with clients and help them navigate their unique challenges, from structural biology and biophysics, to pharmaceuticals, to innovation and communication.

Pharmaceutical Industry
Scientific Illustration
Science
Physical Science
Teaching
Chemistry
Grant Writing
Editing & Proofreading
Writing Critique
Experiment Design
Biochemistry
Research & Development
Line Editing
Grant Writing Consultation
$85 hourly
Matt H.
- 0.0/5
- (0 jobs)
Experienced legal professional with expertise in the pharmaceutical/life science/clinical trials industry. Having worked in both large organizations as well as startups, I understand the challenges within the industry as well as the legal complexities in this space. In my leadership roles, I have helped navigate to achieve key performance metrics and other business objectives while ensuring risk is minimized to the company.

Pharmaceutical Industry
Insurance
Clinical Trial
Legal
Contract Law
Contract Drafting
Legal Agreement
Contract
Budget
Budget Proposal
$74 hourly
Jenna D.
- 0.0/5
- (0 jobs)
Hi! I am Jenna DeVries, creative and avid cheese eater. I am always in pursuit of disruptive ideas that effortlessly tell a story. I have spent over 15 years living and breathing this industry. I have successfully led creative direction and concept development for multi-channel marketing campaigns from brainstorm to execution. Feel free to view to view my work at kumquatrobot.com.

Pharmaceutical Industry
Color Theory
Iconography
Typography
Microsoft Office
Digital Design
Retail Design
Print Campaign
Package Graphics
Logo Design
Layout Design
Brand Strategy
Adobe Creative Cloud
Graphic Design
Brand Development
$22 hourly
Ginger V.
- 0.0/5
- (0 jobs)
Seeking reentry into the private sector by applying my experience and education with the objective of being a positive attribute to your organization

Pharmaceutical Industry
Compliance
Medical Terminology
Insurance
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