Medical Writer II, Oncology

Jobtailor; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

Jobtailor is seeking a Regulatory Medical Writer to author and coordinate oncology-focused clinical documents and regulatory submissions. The role involves writing Phase 1 protocols, Phase 1/2 CSRs, and initial IBs, plus coordinating mid-stage documents and responses. Strong teamwork and communication are essential.

You will manage timelines, mentor junior staff, and collaborate with cross-functional teams to ensure high-quality deliverables in a regulated environment.

Qualifications

• University/college degree in a scientific discipline.
• At least 2 years of relevant pharmaceutical/scientific experience.
• 2 to 4+ years of regulatory medical writing experience.
• Strong oral and written communication skills in English.
• Ability to understand, interpret, and summarize scientific or medical data.
• Ability to function in a team environment and build positive cross-functional relationships.
• Demonstrated problem-solving skills.
• Strong attention to detail.
• Strong time management and project/process management skills.
• Learning agility in interpreting, summarizing, and presenting statistical and medical information.
• Emerging leadership skills in project, process, and time management.
• Knowledge of regulatory guidance documents such as ICH requirements.
• Sound knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.

Responsibilities

• Author and coordinate regulatory medical writing documents supporting the Oncology therapeutic area.
• Write and coordinate basic clinical documents, including Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs.
• Write, contribute to, and coordinate low- to medium-complexity clinical and regulatory documents, including Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses.
• Perform document quality control, prepare abbreviations and references, conduct literature searches, and complete other basic tasks.
• Participate in and potentially lead cross-functional document planning and review meetings.
• Manage project timing, scheduling, tracking, document timelines, and strategies.
• Collaborate with clinical, regulatory, biostatistical, and other cross-functional colleagues.
• Guide or train cross-functional team members on processes and best practices.
• Lead early- or late-stage compound writing teams under supervision.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Mentor junior staff on document planning, processes, content, or peer review.
• Complete time reporting, training, metrics database, and project tracking updates.

Skills

Regulatory Medical Writing

Clinical Document Writing

Project Tracking

Time Management

Mentoring

Literature Search

Data Interpretation

Cross-functional Collaboration

Strong Communication

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

• Author and coordinate regulatory medical writing documents supporting the Oncology therapeutic area


• Write and coordinate basic clinical documents, including Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs


• Write, contribute to, and coordinate low- to medium-complexity clinical and regulatory documents, including Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses


• Perform document quality control, prepare abbreviations and references, conduct literature searches, and complete other basic tasks


• Participate in and potentially lead cross-functional document planning and review meetings


• Manage project timing, scheduling, tracking, document timelines, and strategies


• Collaborate with clinical, regulatory, biostatistical, and other cross-functional colleagues


• Guide or train cross-functional team members on processes and best practices


• Lead early- or late-stage compound writing teams under supervision


• Maintain knowledge of industry, company, and regulatory guidelines


• Mentor junior staff on document planning, processes, content, or peer review


• Complete time reporting, training, metrics database, and project tracking updates

Requirements

• University/college degree in a scientific discipline


• At least 2 years of relevant pharmaceutical/scientific experience


• 2 to 4+ years of regulatory medical writing experience


• Strong oral and written communication skills in English


• Ability to understand, interpret, and summarize scientific or medical data


• Ability to function in a team environment and build positive cross-functional relationships


• Demonstrated problem-solving skills


• Strong attention to detail


• Strong time management and project/process management skills


• Learning agility in interpreting, summarizing, and presenting statistical and medical information


• Emerging leadership skills in project, process, and time management


• Knowledge of regulatory guidance documents such as ICH requirements


• Sound knowledge of Microsoft Word, Excel, PowerPoint, and Outlook

Core Competencies

Demonstrates expertise in regulatory medical writing, including the creation and coordination of clinical documents such as protocols and clinical study reports. Possesses strong project management skills and the ability to collaborate effectively with cross-functional teams while mentoring junior staff.

Highest-signal resume keywords

• Regulatory Medical Writing


• Clinical Document Coordination


• Project Management


• Strong Communication Skills


• Knowledge of ICH Requirements

Hard Skills

• Regulatory Medical Writing


• Clinical Document Writing


• Document Quality Control


• Literature Search


• Data Interpretation


• Project Tracking


• Statistical Summarization


• Mentoring


• Time Management


• Problem-Solving

Soft Skills

• Team Collaboration


• Attention to Detail


• Learning Agility


• Emerging Leadership Skills
  
• Building Cross-Functional Relationships

Industry Keywords

• Oncology


• Phase 1 Protocols


• Phase 2/3 CSRs


• Regulatory Guidelines


• Scientific Discipline

Tools & Technologies

• Microsoft Word


• Microsoft Excel


• Microsoft PowerPoint


• Microsoft Outlook