Audubon Project Management Associates, Inc. (APMA) is seeking experienced medical writers to join its talented team as independent, home-based consultants to support rapid business growth.Exciting opportunities exist for qualified candidates to work directly with our clients on cross-functional project teams to lead the production of high-quality clinical regulatory documents that support drug development projects from Phase I through to Common Technical Document (CTD) submissions and line extensions.
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’ relevant medical writing experience.
Demonstrated knowledge of US, European, ICH and other international regulations including CTD marketing applications.
Strong analytical and conceptual thinking skills.
Excellent written and oral communication skills.
Proven ability to work independently and effectively in teams.
Maintain a home office/workspace that is well equipped to support working remotely.
APMA is a clinical/regulatory writing and project management organization supporting the pharmaceutical industry.APMA’s team of medical writers 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, immuno-oncology, cardiovascular, diabetes, respiratory).A global company, APMA staff are located in the US, UK, Sweden, Finland, France and Australia.
The ideal candidate will possess significant (>3 years) experience authoring clinical regulatory documents at both the study level (eg, CSRs) and project-level (eg, submission high level documents including the Clinical Overview, Clinical Summaries of Efficacy and Safety, ISE/ISS; regulatory response documents, IBs, briefing packages). The ideal candidate will also possess strong communications skills to lead cross-functional teams in the creation and delivery of clinical regulatory documents. Drug development experience across a variety of therapeutic areas and an ability to work independently is a must, while an advanced degree in the sciences preferred.
Internal Number: 1022
About Audubon Project Management Associates Inc.
APMA is a niche CRO providing collaborative support for the submission of regulatory documents. Our highly experienced team comprises regulatory consultants, medical writers, project leads, and document managers with decades of industry experience. Our comprehensive service covers all aspects of regulatory submissions (CTD and non-CTD countries), project management and the production of quality, publication-ready documents for diverse therapeutic and disease areas.