Lead medical and scientific review of promotional and non-promotional materials for assigned products and markets.
Ensure scientific accuracy, regulatory compliance, and fair balance in content, collaborating with cross-functional teams.
Develop and review medical content, including scientific narratives and medical information, adhering to industry standards.
EVERSANA provides next-generation commercialization services to the life sciences industry, helping bring innovative therapies to market. With over 7,000 employees globally, they serve more than 670 clients and are certified as a Great Place to Work.
Own regulatory review and approval of promotional materials across HCP, DTC, digital, and social channels, ensuring compliance with FDA regulations.
Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims, providing clear guidance to reduce approval delays.
Lead FDA promotional submissions, monitor regulatory trends, and build scalable processes to support product launches.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company values Trust, Ownership, Curiosity, and Results, and offers a collaborative, high-achieving environment with a focus on diversity and inclusion.
Ensure marketing, educational, and communications materials comply with FDA, FTC, USP, and state pharmacy regulations.
Lead cross-functional content reviews and provide practical, risk-based compliance guidance to teams.
Develop compliance SOPs, training resources, and auditable documentation to support scalable content operations.
Strive Pharmacy is a personalized compounding pharmacy that creates custom medications tailored to individual patient needs. The company is a growing team focused on disrupting the pharmaceutical industry with a human-centered approach and a collaborative culture.
Serve as the designated Pharmacist in Charge and fulfill all related responsibilities.
Review and approve licensing submissions, renewals, and regulatory documentation.
Collaborate with the operations and compliance team to support ongoing compliance.
MD Exam is a healthcare organization specializing in sterile compounding operations. They are a growing company with an experienced team dedicated to compliance and patient safety.
Build strong scientific relationships with key clinical experts.
Lead scientific discussions and deliver educational presentations.
Support clinical research and gather insights from the field.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues. It is a large global biopharmaceutical company with a collaborative and inclusive culture.
Write PAAB-regulated pharmaceutical advertising copy for HCP and promotional materials.
Collaborate with cross-functional teams and clients to ensure compliance with PAAB review process.
Work independently in a fast-paced agency environment with a remote-first approach.
Klick is an ecosystem of companies dedicated to helping life sciences brands achieve their full potential through marketing, media, and technology. With over 500 in-house medical experts and a people-first culture, Klick is consistently recognized as a top workplace.
Write and develop scientific publications including manuscripts, abstracts, and posters for oncology products.
Review and ensure highest standards of content produced by junior team members.
Provide line management and mentorship to support team development.
Inizio is a strategic partner for health and life sciences, solving health challenges and developing transformational ideas. We are a team of 10,000 experts in 35 countries, fostering an inclusive and empowering culture.
Serve as the designated Pharmacist-in-Charge, reviewing licensing submissions and regulatory documentation.
Work with pharmacy operations and compliance team to support ongoing compliance and Board-related discussions.
Provide professional guidance and identify issues requiring follow-up or corrective action.
MD Exam is a growing healthcare organization with established sterile compounding operations. It offers an experienced team support and a collaborative culture focused on patient safety and compliance.
Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
Manage essential document collection, informed consent customization, and maintain project plans and trackers.
Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.
Develop and write medically accurate content for a variety of resources, including value proposition slide decks, advisory boards, and internal training materials.
Serve as content point person on assigned accounts, ensuring high-quality work under limited supervision and strict timelines.
Collaborate with internal teams and pharmaceutical clients, attend medical/legal/regulatory review meetings, and mentor junior staff.
PRECISION AQ is a top payer marketing agency that supports global pharmaceutical and life sciences clients in commercial excellence. The company focuses on demonstrating the economic, clinical, and societal value of medical treatments to payers, providers, patients, and policymakers.
Develop scientific expertise in assigned therapeutic areas, supporting delivery for a versatile team.
Research and develop technical materials, ensuring accuracy and adherence to editorial style.
Communicate with clients and key opinion leaders on content development and attend scientific meetings.
Nucleus Global is a global leader in medical communications, part of the iNIZIO group, providing advisory, medical, marketing, and engagement services to life sciences companies. With over 900 employees across Europe, US, and APAC, it fosters a friendly and informal working environment with social events and wellbeing programs.
Edit and ensure regulatory compliance for pharmaceutical marketing materials across digital and print channels.
Fact-check and proofread copy to adapt for new channels and audiences, providing medical expertise within FDA guidelines.
Collaborate with cross-functional teams and manage multiple projects in a fast-paced environment.
P10 is a creative agency focused on delivering exceptional value for clients. It is a remote-only team of diverse, seasoned professionals driven by passion and purpose.
Lead end-to-end labeling activities across the product lifecycle for pre- and post-market products.
Guide global labeling strategy, document development, and cross-functional regulatory teams.
Provide strategic labeling expertise to support safe and effective product use and regulatory compliance.
A global regulatory affairs organization focused on pharmaceutical product labeling. It provides a collaborative, science-driven environment with cross-functional and international exposure.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Lead author on complex regulatory and clinical documents including protocols, CSRs, IBs, and IND/NDA/BLA submissions.
Provide strategic input on document planning, messaging, and quality control while mentoring other writers.
Manage multiple projects independently, balancing timelines and client expectations in a fully remote environment.
Eldridge Writing provides top-tier medical writing services to pharmaceutical and biotechnology clients. We are a small, collaborative team that values quality and serves as a true extension of our clients’ teams.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Monitor automated affidavit workflows from generation through completion, identifying affidavits requiring manual intervention.
Review affidavits for accuracy, completeness, and compliance, and serve as an authorized affidavit signer.
Research state and jurisdictional requirements, translate them into clear operational processes, and resolve compliance gaps.
The partner company operates a technology platform that automates affidavit workflows, ensuring accuracy and compliance. The company fosters a mission-driven, remote culture with a focus on process improvement and scalability.
Translate English documents into target languages and deliver responses via phone or in writing.
Triage and respond to drug information inquiries from healthcare professionals and patients.
Identify and intake adverse events and product complaints, ensuring compliance with regulations.
EVERSANA is a global company providing next-generation commercialization services to the life sciences industry, helping bring innovative therapies to market. With over 7,000 employees and serving more than 650 clients, we foster an inclusive culture grounded in strong cultural beliefs.
Provide integrated support to patients and physicians to improve medication adherence and quality of care.
Review patient assessments and EMRs to develop care plans and optimize drug therapies.
Monitor adherence, oversee technicians, and ensure compliance with pharmacy regulations.
Shields Health Solutions provides integrated specialty pharmacy support to patients and physicians. The company emphasizes high-integrity, quality-focused teamwork and confidentiality in a remote work environment.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.