Lead authoring and development of high-complexity Phase II-IV clinical regulatory documents for a top pharma partner.
Own the end-to-end medical writing process from planning through final delivery, ensuring alignment with strategy and timelines.
Coordinate cross-functional teams across geographies and facilitate comment resolution to drive document development.
Fortrea delivers solutions that bring life-changing treatments to patients faster. They are a global organization that empowers employees to shape their own career path with comprehensive training and management support.
Drive growth of Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
Lead strategic sales efforts, identify client needs, and partner cross-functionally to deliver tailored solutions supporting regulatory approvals.
Serve as the primary liaison between client and company for all sales-related activities, enhancing visibility and market presence.
Veristat accelerates life-changing therapies to patients worldwide with more than 30 years of expertise. They have a flexible, inclusive culture with 70% remote workforce and 66% women-led teams, having prepared over 105 approved therapies and delivered over 350 rare disease projects.
Plays an essential role supporting Global Medical Information / Medical Content Development Team on content development-related engagements.
Writes and creates medical and scientific content related to Medical Affairs, Medical Information and Medical Communications.
Drives the client document development process from gathering materials and developing scientifically rigorous content to facilitating document review.
EVERSANA delivers next-generation commercialization services to the life sciences industry, helping bring innovative therapies to market and supporting patients. They have over 6,000 employees, embracing diversity and inclusion to improve patient lives around the world.
Provide subject matter expertise to teams for global disclosure strategies of clinical documents under regulatory requirements.
Manage planning, preparation, and quality control for disclosures, including oversight of vendor deliverables.
Lead development of standard processes and technological solutions to ensure compliance with disclosure regulations.
Pfizer is a global biopharmaceutical company dedicated to discovering and developing innovative therapies. As a large multinational employer with a culture of individual ownership, it employs tens of thousands of people and fosters a collaborative and inclusive environment.
Review, annotate, and amend publication manuscript drafts to tight deadlines.
Work on rapid turnaround deliverables following guidance set by Sci Comms Solutions Lead.
Liaise with Authors to take manuscripts to submission.
Sorcero's medical AI platform transforms life sciences decision-making, accelerating patient access to life-saving treatments. Sorcero is a Certified B Corp headquartered in Washington, DC, recognized by over a dozen awards, including Fast Company's Most Innovative companies of 2024.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Drafts and maintains medical information content for the Medical Information Call Center (MIC).
Provides guidance to Medical Information Managers on drafting standard medical responses and FAQs.
Reviews MIC case records to ensure accuracy of response and compliance with regulations.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for serious diseases. The company is consistently recognized as one of the industry's top places to work, with a diverse and inclusive culture.
Produce high-quality content for diverse medical communications projects, demonstrating excellent scientific understanding.
Develop content with minimal supervision, within budget and on time, using client approval systems.
Attend conferences, present work to clients, and manage day-to-day client communication and relationships.
Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner, they bring together strategy, evidence, engagement, and technology to engineer breakthrough value.
Develop scientific copy for various deliverables on assigned brands and products.
Work independently and collaboratively with medical writers and directors to develop scientifically accurate copy.
Manage workflow for assigned projects and meet associated deadlines.
Real Chemistry is a global agency providing a full suite of services across healthcare communications and marketing to top pharmaceutical and biotech clients. They foster a culture rooted in being best together with a commitment to excellence, offering a comprehensive benefits program and perks.
Support regulatory and quality processes to ensure compliance with applicable requirements, focusing on product design, development, and manufacture of medical devices.
Assist in drafting regulatory submissions for domestic and worldwide commercialization and provide guidance on product labeling and lifecycle planning.
Evaluate regulatory impact of changes, manage product recall activities, and participate in internal and third-party quality audits.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. The company is dedicated to developing better solutions for life from discovery to diagnosis and fosters an innovative culture for talented individuals to solve tough problems.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
Focus on mastering scientific content, disease state, and therapeutic area to serve as a scientific expert.
Identify, develop, and maintain professional relationships with thought leaders, academic centers, and researchers.
Present scientific information and education to healthcare professionals across the product lifecycle.
AbbVie discovers and delivers innovative medicines and solutions in immunology, oncology, neuroscience, and aesthetics. A global pharmaceutical company with a commitment to integrity and innovation, employing thousands worldwide and fostering a culture of inclusion and community service.
Lead scientific content planning and oversight for assigned accounts across therapeutic areas.
Manage client interactions, brand strategy, and business development for large accounts.
Must have 8+ years experience in promotional medical education, with oncology expertise required.
Lockwood collaborates with pharmaceutical, biotech, and medical device clients to develop evidence-based medical communications strategies. Over a third of staff hold advanced scientific or medical degrees, and the company's flexible structure supports work-life balance and attracts top talent.
Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.
Develop, execute, monitor, and adapt strategic MSL stakeholder engagement plans.
Lead high-quality scientific exchange through both proactive and reactive interactions.
Identify and communicate insights, trends, and activities of other Medical Affairs organizations.
They focus on engaging key opinion leaders (KOLs) and healthcare providers in high-quality scientific exchange. They drive insight generation and contribute to the development and execution of medical strategy.
Manage a team of 15-17 Study Management Associates (SMAs) to deliver best-in-class study execution.
Drive performance management, mentoring, and professional development for direct reports.
Support resource management, adherence to regulations, and continuous process improvements.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates across several therapeutic areas including immunology, oncology, and neuroscience, with a significant global presence and a culture focused on innovation and impact.
You will co-lead a large global publications and medical affairs team in breast cancer, ensuring high-impact deliverables.
You will develop accurate and high-quality scientific content across diverse publications and medical affairs projects.
You will mentor and oversee junior writers, build strong client relationships, and drive account growth.
Nucleus Global is a global leader in the medical communications space, with more than 900 people across Europe, the US and APAC. We pride ourselves in setting the standard for industry best practices, with our unparalleled dedication to impactful and innovative communication.
Perform copy-edit and translation tasks on clinical and regulatory documents for assigned projects.
Manage language resources, resolve terminology queries, and coordinate with freelancers and internal teams.
Ensure high-quality linguistic deliverables, meet KPIs, and contribute to process improvements.
Welo Life Sciences is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations in regulated global markets. They deliver ISO-certified translation, linguistic validation, and localization solutions with a secure, audit-ready framework.