Audubon’s primary mission is to deliver exceptional service and exceed our clients’ expectations. This reputation is the cornerstone of our organization and is the reason we have the opportunity to work on such a variety of exciting and challenging projects in the pharmaceutical and biotech industries. We are proud of our managed, responsive growth and are always willing to talk to pharmaceutical industry professionals seeking to make a difference on global regulatory submission teams.
Our vision is a work environment where our Associates can work on spectacular projects and breakthrough therapies in a setting where professionalism matters and where daily work is purposeful, challenging, and rewarding.
Audubon appreciates inquiries and accepts resumes from prospective candidates with medical writing, document publishing, and project management expertise for potential consideration.
Job Openings
Medical Writer
We are seeking experienced medical writers to join our talented team of remote, networked Associates. Exciting opportunities exist for qualified candidates to work with our pharmaceutical clients on high-quality clinical regulatory documents that support drug development projects, from early stage through to Common Technical Document (CTD) submissions and line extensions.
Working as an APMA Associate is especially attractive to freelance professionals who have hitherto been working alone. APMA’s remote team-based approach provides medical writers with the support of project managers, independent QC reviewers, and document managers, backed by IT support and a secure IT platform. This opens up many more opportunities to work on a broader range of projects and respond more easily to changing project demands.
The ideal candidate will have a thorough understanding of the global regulatory submission process (for drugs and/or biologics) and possess significant (>3 years) experience authoring clinical regulatory documents at either (or both) the study level (eg, clinical study protocols and reports; patient narratives) and project level (eg, high-level documents for marketing applications, including Clinical Overviews, Clinical Summaries of Efficacy and Safety, and ISE/ISS; regulatory response documents; Investigator’s Brochures; briefing packages). The ideal candidate will also possess strong communications, organizational and interpersonal skills to work with project teams in the creation and delivery of clinical regulatory documents to support global submissions. Drug development experience across a variety of therapeutic areas and an ability to work independently are important attributes. An advanced degree in life sciences is preferred.
Our teams of medical writers, project managers, and document managers, work with mid-size and large pharmaceutical companies to provide high-quality global clinical regulatory documents that support drug development projects from IND through life-cycle management, across diverse therapeutic and disease areas (eg, cardiovascular, metabolic disorders, respiratory, immunology, oncology, vaccines/infectious disease, and rare diseases). We currently contract with medical writers based in the US, UK, Europe, and Australia, and are expanding our global footprint.
Desired skills and experience
The following skills and experience are desired:
Advanced degree (MS, PhD, MD, PharmD) in life sciences preferred with at least 3+ years’ medical writing or relevant experience.
Demonstrated knowledge of US, European, ICH and other international regulations including Clinical Study Reports and CTD marketing applications.
Strong analytical and conceptual thinking skills.
Excellent written and oral communication skills.
Proven ability to work independently and effectively in teams.
Possess a home office that is well equipped to support working remotely.
To apply, please send your details to info@audubonpm.com