Overview
Lead Medical Writer role at Integrated Resources, Inc. (IRI). Duration: 24 months. Location: Remote. Base pay range: $64.00/hr - $69.00/hr. This description reflects the responsibilities and qualifications for the Medical Writer III / Associate Director Medical Writer position as posted by IRI.
Job Description
The primary responsibilities of an Associate Director Medical Writer include leading key medical writing projects across therapeutic areas and preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. Documents may include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of INDs and NDAs/BLAs (e.g., integrated summaries of safety and efficacy, product labeling, and summaries of nonclinical and clinical information). The role requires broad experience in pharmaceutical medical writing and knowledge of current regulatory guidelines.
Responsibilities
- Serve 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.
- Contribute to the development of the submission communication strategy for a product.
- Interpret and summarize data from biostatistical summaries and listings into clear narrative text.
- Liaise with internal groups (Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, R&D Management) to obtain necessary information and ensure timely production of reports.
- Oversee and review work of other medical writers and agencies, with support from the Director of Medical Writing.
- Foster innovation and process improvements in medical writing with support from the Director of Medical Writing.
- Perform other responsibilities as assigned.
Requirements & Skills
- American Medical Writing Association (AMWA) certification or equivalent is desirable, with a specialty in Pharmaceutical Writing.
- 3+ years of medical writing experience in the pharmaceutical industry, focused on regulatory document preparation; understanding of drug development and regulatory guidelines.
- Specific experience with CNS/Neuroscience compounds.
- Ability to manage projects independently and lead cross-functional teams.
- Strong writing skills and ability to convert scientific data into a clear, scientifically sound narrative.
- Ability to self-edit for readability, accuracy, consistency, and presentation of data.
- Knowledge of clinical trial and drug development processes; familiarity with US, ICH, and international regulations for scientific and regulatory document submissions.
- Knowledge of Common Technical Document content templates and content expectations for IND/NDA/MAA submissions.
- Experience with electronic document management systems and publishing systems.
- Ability to translate information for appropriate audiences and to communicate complex concepts clearly.
- Proficiency with Windows software for word processing, diagrams, and spreadsheets.
- Ability to learn quickly and turn scientific data into high-quality summaries; openness to feedback and improvement; ability to work collaboratively.
- Ability to evaluate situations and recommend changes based on project needs.
Education
- PhD in life sciences or PharmD preferred with 5+ years of relevant experience; or MS with 7+ years of relevant experience.
Seniorities and Employment
- Seniority level: Mid-Senior level
- Employment type: Contract
- Job function: Research
- Industries: Pharmaceutical Manufacturing and Biotechnology Research
For context, the posting includes additional job suggestions and regional listings, but the core responsibilities and qualifications above reflect the role described by Integrated Resources, Inc. (IRI).