Our client develops and commercializes therapies for hallucinations and delusions associated with Parkinson’s disease.

Position Summary:.

The primary responsibilities of an Associate Director Medical Writer include, but are not limited to, leading key medical writing projects and activities across therapeutic areas and preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics.
These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information).
The Associate Director Medical Writer has a broad range of experience in pharmaceutical medical writing and clinical/pharmaceutical development and knowledge of current regulatory guidelines.

Primary Responsibilities:

Acts as medical writing point person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions.
Participates in and contributes to the development of the submission communication strategy for a product.
Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text.
Liaises with internal groups, i.e., Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations and R&D Management to obtain necessary information and to ensure the timely implementation of activities related to the production of reports.
Interacts with and oversees, coordinates and reviews the work of other medical writers, including freelance/contract medical writers and agencies, with support from Director Medical Writing.
Fosters innovation and improvement related to medical writing processes and documents, with support from Director Medical Writing.
Other responsibilities as assigned.

Scope:

Uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Determines methods and procedures on new assignments.

Compass Consulting

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