Audubon PM Associates, Inc. (APMA) - Experienced medical writers - Remote

Job description
Audubon PM Associates, Inc. (APMA) is seeking experienced medical writers to join its talented team of remote, networked-based consultants. Exciting opportunities in the pharmaceutical industry exist for qualified candidates to work with our clients on cross-functional project teams to lead the production of high-quality clinical regulatory documents that support drug development projects from an early stage through to Common Technical Document (CTD) submissions and line extensions.

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.

Entry-level medical writing candidates who can demonstrate the ability to communicate clearly and effectively, both verbally and in writing, display strong leadership and effective project management skills in a team-based environment, and possess strong analytical and conceptual skills along with a solid science background will also be considered.

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.

About this company
Audubon PM Associates, Inc. (APMA) is a clinical/regulatory writing and project management CRO supporting the pharmaceutical industry. APMA’s 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). APMA currently contracts with medical writers based in the US, UK, Europe, and Australia, and is expanding its global footprint.

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