Job Description

I am currently partnered with a growing pharmaceutical company in New York City who is looking to add a highly collaborative Associate Director, Medical Writer of Clinical Development to their team! The Associate Director will draft, edit and submit high quality, medically accurate documents including protocols, clinical study reports, manuscripts, conference abstracts, and posters.

This is a key position within CNS scientific communication with ample opportunity to make real impact. The Medical Writer reports to the Head of Clinical Development, and collaborates with the overall scientific team.

Job Responsibilities and Duties include, but are not limited to, the following:

• Interpret complex data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, publications and other documents in support of Medical Affairs, RWE/HEOR and/or Clinical Development programs
• Attends strategic meetings as applicable
• Closely collaborates with, and apply applies strategic direction from, project and publication leads, and biostatisticians in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals
• Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs). (Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus)
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)
• This may include developing timelines, review/approval workflow management, and/or QC/publication readiness
• Works with cross-functional internal teams to ensure wide acceptability of documents and consensus of content
• Oversees outsourced medical writings projects and the associated vendor(s), as applicable
• Critically analyzes, synthesizes, and presents complex information
• Drives Results
• Ensures Accountability

Requirements / Qualifications

• Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 5-8 years relevant experience
• A strong current working knowledge of the pharmaceutical environment is required.

Experience and Knowledge:

• Highly knowledgeable in the relevant CNS therapeutic area
• Track record of developing high-quality scientific documents
• Ability to interpret, evaluate, and communicate (in a variety of formats and styles) complex scientific and clinical data
• Expertise in use of online and other data sources for literature searches and information
• General knowledge of the drug development and approval processes and GXP principles
• Ability to work with cross-functional executive leadership and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
• Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment

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