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.
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.
Draft and copyedit submissions for abstracts, posters and peer-reviewed manuscripts.
Work collaboratively with other team members and actively participate in pub planning activities.
Perform fact/data check on writing documents (manuscripts, white papers, dossiers, etc.).
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated professionals from world-class institutions, who care deeply for our work and each other.
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.
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.
Develop client-ready deliverables including protocols, statistical analysis plans, and technical reports.
Manage the delivery of project components by collaborating with other staff members.
Contribute to development of proposals and presentations under guidance of senior team members.
Precision Medicine Group is a portfolio organization that helps its clients with sophisticated evidence synthesis projects. The company has a start-up culture with vision in its field.
Review, draft, and negotiate clinical trial agreements and budgets across European sites.
Serve as a subject matter expert and mentor to staff on contract management processes.
Coordinate with study teams and sponsors to ensure contract execution aligns with study timelines.
Precision for Medicine is a life sciences company that provides clinical research services. They are an established organization with a focus on supporting clinical trials and employ a global team with a culture of collaboration and professionalism.
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.
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.
Manages complex cross-functional design and development projects on a first in class wearable device.
Works with cross-functional team to ensure timely and complete deliverable execution.
Identifies, analyzes, and tracks project risks and issues and monitors progress to plan.
Cognito Therapeutics, Inc. translates scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. They are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world.
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.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
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.
Lead development of resumes and project datasheets tailored to specific pursuits.
Conduct direct interviews with project teams and SMEs to capture construction approach, technical challenges, and safety performance.
Manage proposal compliance and administrative requirements, coordinate proposal schedules and improve proposal content libraries.
Shimmick Construction and Axia Electric deliver complex infrastructure across water, transportation, energy, and marine markets. They have self-perform capabilities, technical expertise, and disciplined execution building a proposal team that reflects that same standard.
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.