Associate Director Medical Writer

Integrated Resources, Inc ( IRI ); United States; Remote; USD 70.000 - 90.000; Teilzeit

Zusammenfassung

A leading medical writing organization is seeking a qualified Associate Director Medical Writer to lead medical writing projects for clinical development. The candidate should have experience in regulatory document preparation and a strong background in CNS/Neuroscience. This part-time position offers the potential for full-time work based on performance and operates remotely.

Qualifikationen

• 3+ years in medical writing for the pharmaceutical industry.
• Specific experience working with CNS/Neuroscience compounds required.
• Ability to convert scientific data into clear, well-structured narratives.

Aufgaben

• Lead key medical writing projects and activities across therapeutic areas.
• Prepare scientific and regulatory documents related to clinical development.
• Foster innovation and improvement related to medical writing processes.

Kenntnisse

Medical writing

Regulatory document preparation

Strong writing skills

Project management

Knowledge of regulatory guidelines

Ausbildung

PhD in a life science/Pharm D preferred

MS with 7 or more years of relevant experience

Tools

Electronic document management systems

Word processing software

Jobbeschreibung

Title: Associate Director Medical Writer

Location: REMOTE

Duration: 24+ months (Possibility of extension)

Schedule: Initially, only ~15-25 hours per week are utilized for onboarding and training. If performance is strong, this position could be full time.

Responsibilities

• 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.
• 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.
• Phase 1 pharmacology experience with protocols is a MUST.

Requirements & Skills

• American Medical Writing Association (AMWA) certification or other is desirable, with a specialty in Pharmaceutical Writing.
• 3+ years’ in medical writing for the pharmaceutical industry, with a focus on regulatory document preparation; knowledge of drug development process and regulatory guidelines.
• Specific experience working with CNS/Neuroscience compounds.
• Ability to manage projects independently and lead/organize/participate in cross-functional teams.
• Journalism/press publications.
• Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured ‘story’.
• Ability to self-edit and improve own work to ensure readability, accuracy, consistency and aesthetic presentation of data and information.
• Knowledge of clinical trial and drug development processes.
• Knowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissions.
• Knowledge of Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation.
• Working knowledge of current electronic document management systems and publishing systems.
• Ability to assimilate, interpret and translate information/data for appropriate audiences.
• Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets.
• Ability to learn fast, grasp the 3sence a story quickly to convert relevant scientific data/information into high quality summaries and reports.
• Open to feedback and suggestions and innovation for improvement.
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
• Skilled at creating a cooperative team environment.
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.

Education

• A PhD in a life science/Pharm D preferred with 5 or more years of relevant experience; MS with 7 or more years of relevant experience.

Seniority level

• Mid-Senior level

Employment type

• Part-time

Job function

• Science, Research, and Writing/Editing
• Industries
• Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing