APMA - Medical Writers - Home based
Audubon PM Associates
Home-based medical writers wanted (all levels considered)
Audubon Project Management Associates (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.
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. Entry-level medical writing candidates who can demonstrate key core capabilities (eg, strong leadership and project management skills; science background; publications experience) will be considered.
Desired skills and experience
The following skills and experience are desired:
• Advanced degree (MS, PhD, MD) 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.
• Possess or be willing to provide a home office 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, oncology, cardiovascular, diabetes, respiratory). A global company, APMA associates are located in the US, UK, Sweden and Australia.
Interested candidates should send a covering letter and CV to: firstname.lastname@example.org