Medical Writer III

Planet Pharma; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Medical Writer III to manage key writing projects. This remote role involves preparing scientific documents and collaborating with various departments. Ideal candidates will have a strong background in writing, regulatory knowledge, and experience in the pharmaceutical sector. The position offers flexibility in hours and a competitive hourly rate, with a focus on quality and innovation in medical writing.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Minimum of 3 years in the pharmaceutical industry, with at least 5+ years preferred.
• AMWA certification required.

Responsibilities

• Lead preparation of clinical summaries and regulatory submissions.
• Collaborate with internal departments for timely report production.
• Oversee freelance medical writers.

Skills

Certification

Phase I pharmacology experience

Neuroscience/CNS experience

Strong writing skills

Regulatory Knowledge

Education

MS

PhD

Job description

Direct message the job poster from Planet Pharma

• Location: Remote - Open to any time zone, with a preference for candidates in proximity to Princeton, NJ.
• Urgency: Looking to fill quickly
• Contract Length: 12-month contract with potential for extension
• Target Hourly Rate: $66/hr. with flexibility
• Hours: Initially 20 hours/week, ramping up to 30-40 hours/week as training progresses and the writer works more independently.
• Education: MS required, PhD preferred.
• Experience: Minimum of 3 years in the pharmaceutical industry, with at least 5+ years preferred.

Position Summary:

The Medical Writer III is responsible for leading key medical writing projects and activities across various therapeutic areas. This role involves preparing scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. The Medical Writer III will work independently on clinical study reports (CSRs), subject narratives, protocols, and regulatory submissions such as INDs and NDAs/BLAs, with minimal supervision.

Top 5 Skills:

• Certification: AMWA certification required.
• Phase I pharmacology experience with protocols is mandatory.
• Experience with Common Technical Document content, IND/NDA submissions, and regulatory documentation is a plus.
• Ability to use electronic document management and publishing systems efficiently.
• Neuroscience/CNS experience in medical affairs is highly preferred.

Primary Responsibilities:

• Lead the preparation of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, and literature reviews for regulatory submissions.
• Contribute to the development of submission communication strategies for pharmaceutical products.
• Summarize complex biostatistical data into clear, concise narrative text.
• Liaise with internal departments (e.g., Biostatistics, Data Management, Regulatory Affairs, Clinical Development) to gather necessary information and ensure timely production of reports.
• Collaborate with and oversee freelance/contract medical writers and agencies.
• Contribute to innovation and improvements in medical writing processes and documents.
• Perform other related tasks as assigned.

Scope:

• Use professional concepts and company objectives to resolve complex issues creatively and effectively.
• Independently determine methods and procedures for new assignments, using judgment to select techniques and evaluation criteria.
• Handle complex situations requiring an in-depth evaluation of variable factors.

Physical Requirements:

• Frequent sitting, standing, walking, and use of hands for typing and handling materials.
• Occasional lifting (up to 20 pounds).
• Occasional overnight travel may be required.

Skills & Qualifications:

Required:

• Education: MS required, PhD preferred.
• Experience: Minimum of 3 years in the pharmaceutical industry, with at least 5+ years preferred.
• Certification: AMWA certification required.
• Technical Skills: Strong writing skills and the ability to convert complex scientific data into clear, scientifically accurate narratives.
• Regulatory Knowledge: Familiarity with US, ICH, and international regulations for scientific and clinical/regulatory documents.

Experience:

• Phase I pharmacology experience with protocols is mandatory.
• Neuroscience/CNS experience in medical affairs is highly preferred.
• Ability to manage projects independently and work within cross-functional teams.
• Experience with Common Technical Document content, IND/NDA submissions, and regulatory documentation is a plus.
• Ability to use electronic document management and publishing systems efficiently.
• Skilled in converting scientific data into high-quality summaries and reports quickly.

Preferred:

• Specific experience working with CNS/Neuroscience compounds.
• Ability to self-edit and improve own work for readability, accuracy, and consistency.
• Expertise in clinical trial processes and drug development.
• Proficiency in word processing, spreadsheets, and flow diagrams.
• Strong communication skills and ability to foster a cooperative team environment.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Writing/Editing and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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