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Pharmaceutical Consultant Writer – Remote

IntelliPro Group Inc.
Full-time
Remote
Worldwide
✍️ Copywriting & Content Writing

πŸ“Œ Core Information

πŸ”Ή Job Title: Pharmaceutical Consultant Writer – Remote

πŸ”Ή Company: IntelliPro Group Inc.

πŸ”Ή Location: Durham, North Carolina, United States

πŸ”Ή Job Type: Part-Time, Temporary (7 months with possible extension)

πŸ”Ή Category: Medical Writing, Pharmaceutical, Biotech

πŸ”Ή Date Posted: July 7, 2025

πŸ”Ή Experience Level: 5-10 years

πŸ”Ή Remote Status: Remote (100%)

πŸš€ Job Overview

Key aspects of this role include:

  • Providing medical writing direction and guidance for various projects
  • Ensuring documentation aligns with the client's style guide and regulatory standards (US and EMA)
  • Working collaboratively with cross-functional teams
  • Conducting literature searches and synthesizing information
  • Maintaining expert knowledge of US and international regulations, requirements, and guidance

ASSUMPTION: This role requires a high level of expertise in medical writing and regulatory affairs within the pharmaceutical or biotech industry.

πŸ“‹ Key Responsibilities

βœ… Provide medical writing direction and guidance aligned with the client’s style guide for assigned projects, including the review of work products.

βœ… Convert relevant data and information into formats that comply with TM document requirements and coordinate the review of the final products.

βœ… Understand, assimilate, and interpret various sources of information with appropriate guidance and direction from the TM team.

βœ… Confirm the completeness and accuracy of information presented in documents.

βœ… Perform literature searches as needed to gather relevant content for drafting documents.

βœ… Maintain expert knowledge of US and international regulations, requirements, and guidance associated with scientific publications, including US FDA and ICH guidelines.

βœ… Utilize prior knowledge of preclinical strategy, pharmacology, toxicology, and GLP practices to ensure that documents drafted at AskBio are prepared for regulatory inspection or audit in the US or Europe.

βœ… Complete draft reports based on data provided by AskBio Subject Matter Experts (SMEs) to ensure thoroughness and compliance.

βœ… Review draft training modules on GLP’s, regulatory writing and FDA interactions and provide suggestions on ways to modernize.

ASSUMPTION: This role involves a high degree of autonomy and requires strong self-management skills.

🎯 Required Qualifications

Education: Advanced degree in Life Sciences, Pharmacy, or a related field.

Experience: Proven experience in medical writing within the pharmaceutical or biotech industry (5-10 years).

Required Skills:

  • Expertise in regulatory requirements and guidance related to scientific publications
  • Excellent analytical skills and attention to detail
  • Ability to work collaboratively with cross-functional teams and communicate effectively
  • Proficient in conducting literature searches and synthesizing information
  • Excellent knowledge of English language

Preferred Skills:

  • Regulatory Affairs Certification and/or PMP certification
  • Experience with US FDA and ICH guidelines
  • Knowledge of preclinical strategy, pharmacology, toxicology, and GLP practices

ASSUMPTION: Candidates with additional language proficiency (e.g., Spanish, French, German) may have an advantage for certain projects.

πŸ’° Compensation & Benefits

Salary Range: $90 per hour on W2. This is an industry-standard rate for a medical writer with 5-10 years of experience in the pharmaceutical or biotech industry.

Benefits:

  • Comprehensive benefits package, subject to eligibility

Working Hours: 20 hours per week. This role offers a flexible work arrangement, allowing for a healthy work-life balance.

ASSUMPTION: The salary range provided is based on industry standards for this role and experience level. Benefits may vary based on the candidate's eligibility and IntelliPro's benefits policies.

πŸ“Œ Applicant Insights

πŸ” Company Context

Industry: Staffing and Recruiting. IntelliPro Group Inc. is a global leader in talent acquisition and HR solutions, with a dynamic presence in over 160 countries.

Company Size: 501-1,000 employees. As a mid-sized company, IntelliPro offers a balance between the agility of a startup and the resources of a larger enterprise.

Founded: 2009. IntelliPro was founded with a commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships.

Company Description:

  • IntelliPro is a global leader connecting individuals with rewarding employment opportunities
  • Dedicated to understanding career aspirations and providing equal opportunities
  • Committed to diversity, inclusivity, and accommodating the needs of all applicants

Company Specialties:

  • Executive Search
  • Recruiting
  • Consulting
  • Outsourcing
  • Staff Augmentation
  • Training
  • Comprehensive HR Services

Company Website: http://intelliprogroup.com/

ASSUMPTION: IntelliPro's extensive global presence and expertise in talent acquisition make it an attractive employer for medical writers seeking international exposure.

πŸ“Š Role Analysis

Career Level: Mid-level to Senior. This role requires a high level of expertise and experience in medical writing and regulatory affairs.

Reporting Structure: This role reports directly to the TM team and works collaboratively with cross-functional teams.

Work Arrangement: Remote (100%). This role offers a fully remote work arrangement, allowing for flexibility and work-life balance.

Growth Opportunities:

  • Potential for project extensions and long-term opportunities
  • Possibility of working on diverse projects across various therapeutic areas
  • Chance to develop expertise in regulatory writing and FDA interactions

ASSUMPTION: This role offers opportunities for professional growth and development within the medical writing and regulatory affairs field.

🌍 Location & Work Environment

Office Type: Remote. This role does not require a physical presence in the office, allowing for a flexible work arrangement.

Office Location(s): Durham, North Carolina, United States. IntelliPro's headquarters are located in San Jose, California, but this role can be performed remotely from anywhere in the US.

Geographic Context:

  • Durham is part of the Research Triangle region, known for its strong biotech and pharmaceutical industries
  • The area offers a high quality of life, with a vibrant cultural scene, excellent schools, and a moderate cost of living
  • Durham is located in the eastern part of North Carolina, approximately 25 miles from Raleigh and 15 miles from Chapel Hill

Work Schedule: Flexible. This role offers a flexible work schedule, allowing for a healthy work-life balance.

ASSUMPTION: The remote work arrangement and flexible work schedule make this role an attractive opportunity for medical writers seeking a balance between work and personal life.

πŸ’Ό Interview & Application Insights

Typical Process:

  • Online application submission
  • Phone or video screening
  • In-depth interview with the TM team
  • Background check and offer

Key Assessment Areas:

  • Medical writing expertise and regulatory knowledge
  • Analytical skills and attention to detail
  • Collaboration and communication skills
  • Cultural fit with IntelliPro's values and work environment

Application Tips:

  • Highlight relevant medical writing experience and regulatory knowledge in your resume
  • Tailor your cover letter to emphasize your fit for this specific role and company
  • Prepare examples of your medical writing work, if applicable
  • Research IntelliPro's company culture and values to demonstrate your fit during the interview

ATS Keywords: Medical Writing, Regulatory Affairs, Pharmaceutical, Biotech, FDA, ICH, Attention to Detail, Collaboration, Communication, Literature Searches, Data Interpretation, Project Management, Training Module Review

ASSUMPTION: Applicants should focus on demonstrating their medical writing expertise and regulatory knowledge throughout the application and interview process.

πŸ› οΈ Tools & Technologies

  • Microsoft Office Suite (Word, Excel, PowerPoint)
  • Adobe Acrobat
  • Regulatory submission software (e.g., eCTD, Veeva Vault)
  • Literature search databases (e.g., PubMed, Embase)

ASSUMPTION: Familiarity with these tools and technologies is expected for a medical writer with 5-10 years of experience in the pharmaceutical or biotech industry.

πŸ‘” Cultural Fit Considerations

Company Values:

  • Integrity
  • Expertise
  • Collaboration
  • Innovation
  • Diversity & Inclusion

Work Style:

  • Results-driven
  • Team-oriented
  • Adaptable and flexible
  • Attention to detail
  • Strong communication skills

Self-Assessment Questions:

  • Do you have a strong commitment to integrity and ethical practices in medical writing?
  • Are you comfortable working collaboratively with cross-functional teams and communicating effectively?
  • Can you adapt to new tools, technologies, and work environments as needed?

ASSUMPTION: Applicants should assess their fit with IntelliPro's values and work style to ensure a successful and satisfying work experience.

⚠️ Potential Challenges

  • Meeting tight deadlines and managing multiple projects simultaneously
  • Keeping up with evolving regulatory requirements and guidance
  • Adapting to a fully remote work arrangement, if not already experienced
  • Navigating a large, global organization with a diverse range of projects and clients

ASSUMPTION: These challenges can be overcome with strong time management skills, adaptability, and a proactive approach to learning and development.

πŸ“ˆ Similar Roles Comparison

  • This role differs from other medical writing positions in its focus on regulatory writing and compliance with US and international regulations
  • Industry-specific context: The pharmaceutical and biotech industries are highly regulated, requiring a strong understanding of regulatory requirements and guidance
  • Career path comparison: This role can lead to senior medical writing positions, regulatory affairs roles, or project management opportunities within the pharmaceutical or biotech industry

ASSUMPTION: Applicants should consider their long-term career goals and how this role aligns with their desired career path.

πŸ“ Sample Projects

  • Drafting and reviewing regulatory documents (e.g., IND, NDA, BLA) for pharmaceutical or biotech products
  • Conducting literature searches and synthesizing information for regulatory submissions or publications
  • Reviewing and updating training modules on GLP’s, regulatory writing, and FDA interactions

ASSUMPTION: These sample projects illustrate the diverse range of responsibilities and opportunities available in this role.

❓ Key Questions to Ask During Interview

  • Can you describe the typical projects I would be working on in this role?
  • How does IntelliPro support the professional development and growth of its medical writers?
  • What is the team structure and how does this role fit within the organization?
  • How does IntelliPro ensure the quality and consistency of medical writing across various projects and clients?
  • What is the work-life balance like for medical writers at IntelliPro?

ASSUMPTION: Applicants should use the interview process to gather information about the role, the team, and the company to ensure a good fit.

πŸ“Œ Next Steps for Applicants

To apply for this position:

  • Submit your application through this link
  • Tailor your resume to highlight your medical writing experience and regulatory knowledge
  • Write a cover letter emphasizing your fit for this specific role and company
  • Prepare examples of your medical writing work, if applicable
  • Follow up with IntelliPro one week after submitting your application to confirm receipt and inquire about next steps

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.