Generate content outlines that contain a clearly highlighted story arc and a complete reference list.
Develop client-ready drafts of content in various forms (slide decks, summaries, meeting materials).
Confer with teams in the medical/legal/regulatory review process, answering queries and implementing the required changes.
Precision Medicine Group translates the science of medicine into high-level strategy, tactical communication, and flawless execution. They have long-tenured relationships with major pharmaceutical companies and leading biotech firms, holding a leadership position in strategic medical communication and training solutions.
Implement action plans for approval of submissions.
Improve internal processes and foster relationships.
They are a company using AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Advise on regulatory compliance matters across jurisdictions.
Support business units on pharmacy operations and supply chain issues.
Assist with responses to regulatory inquiries and complaints.
Hims & Hers is a health and wellness platform that aims to improve people's health through accessible care. They are a public company traded on the NYSE with a talent-first flexible/remote work approach.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Be the RA representative on core functional teams for advertising and promotion and global software regulatory classification.
Work closely with SW development, engineering, architect, quality and cybersecurity teams.
Represent RA in the assessment of global cybersecurity and data privacy initiatives.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They have broadened their vision beyond diabetes to empower people to take control of their health with personalized, actionable insights. Dexcom has thousands of ambitious, passionate people worldwide.
Independently develop high-quality, medically accurate content.
Collaborate with internal teams to create compelling content.
Liaise with clients and stakeholders on strategy and content.
Precision AQ is a payer marketing agency that supports global pharmaceutical and life sciences clients in achieving commercial excellence. They focus on demonstrating the value of medical treatments to various stakeholders, contributing to improved patient care worldwide.
The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA).
The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders.
As a core member of the Global Regulatory Team(s) (GRT) for assigned product(s), the GLL ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets.
Sobi is dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
Co-ordinate and compile regulatory submissions and agency correspondence for assigned projects
Implement action plans to achieve timely approval of submissions ensuring compliance
Participate in and support project teams to achieve regulatory goals
Jobgether is acting as a job platform partnering with other companies. They utilize an AI-powered matching process to ensure fair application reviews, identifying top candidates for client companies, though final hiring decisions are managed by the client's internal team.
Serves as a source of medical expertise for clinical project teams.
Provides medical input into the design, planning, initiation and completion of clinical trials.
Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions.
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology. They are advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction and seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.
Review medically complex claims, pre-authorization requests, appeals, and fraud/abuse referrals.
Assess payment determinations using clinical information and established guidelines.
Evaluate medical necessity, appropriateness, and reasonableness for coverage and reimbursement.
Broadway Ventures transforms challenges into opportunities with expert program management, cutting-edge technology, and innovative consulting solutions. As an 8(a), HUBZone, and Service-Disabled Veteran-Owned Small Business (SDVOSB), they empower government and private sector clients by delivering tailored solutions that drive operational success, sustainability, and growth.
Lead the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.
Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
Provide regulatory intelligence—monitoring federal and other regulatory activity and synthesizing developments into clear, actionable insights for internal teams.
Hims & Hers is a health and wellness platform with a mission to improve health around the world. They are customer-centric, and focused on affordability, access, and personalized care. Hims & Hers is a public company traded on the NYSE under the ticker symbol “HIMS”.
Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs.
Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products.
Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.
Centessa Pharmaceuticals is a pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity.
Support content development needs of the Clinical Services department.
Act as the medical lead in the creation and presentation of strategic plans.
Supervise 6+ Clinical Services team members directly and indirectly.
Precision AQ supports global pharmaceutical and life sciences clients in the achievement of commercial excellence. They excel at demonstrating the economic, clinical, and societal value of creative medical treatments. The company has a client service, purpose, accountability, mutual respect and collaboration culture.
Conduct coverage reviews based on member plan benefits and policies.
Document clinical review findings, actions, and outcomes.
Communicate and collaborate with providers for benefit determinations.
Capital Blue Cross promises to go the extra mile for their team and community. They foster a flexible environment where health and wellbeing are prioritized and employees consistently vote it as one of the "Best Places to Work in PA."
Review payer PA policy documents for specialty medications and interpret coverage criteria.
Translate policy language into standardized, structured data fields.
Flag ambiguous, conflicting, or unclear policy language.
Quantile Health is a New York-based AI startup focused on expanding patient access to medicines and cutting commercial research costs for the life science industry. They are a fast-growing company using AI agents.
Direct publication planning aligned to company goals.
Lead cross-functional teams to implement publication plans.
Provide scientific expertise for all publications.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint, looking for high-impact individuals.
Support registrations, submissions, and lifecycle maintenance activities.
Help maintain and improve QMS processes and records to support ISO 13485 certification.
Receive, log, review, and route product complaints for investigation.
Dandy is transforming the antiquated dental industry through technology. Backed by leading venture capital firms, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams to achieve more for their practices, their people, and their patients.
Facilitate complaint investigations and ensure completeness of complaint files.
Evaluate complaints and perform preliminary investigations, following up with healthcare professionals.
Ensure complaint documentation complies with regulatory requirements and coordinate investigations with Quality and R&D.
Calyxo, Inc. is a medical device company that aims to improve kidney stone treatment. They are headquartered in Pleasanton, California, and are led by executives and investors with a proven track record.
Support senior leaders and team and serve as a flexible resource across Medical Affairs projects.
Manage schedules, including calendar management, meeting scheduling, travel arrangements and expenses.
Assist with the preparation of presentations, and other materials as needed.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company with employees working collaboratively.
Reviewing patient care notes for clinical data needed for approvals and care plan recommendations.
Monitoring patient adherence across all sites and disease categories.
Recommending alternative therapeutic drug regimens and disease specific treatments according to guidelines.
Shields Health Solutions provides integrated support to patients and physicians. They improve the quality of patient care by personalizing relationships with patients and prescribers to improve medication adherence and promote evidence-based care.