Medical Writer II, Oncology

Get 360Pharma; Leiden; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Get 360Pharma is seeking a Medical Writer II, Regulatory Medical Writing to support Oncology within our Integrated Data Analytics & Reporting (IDAR) business. The position is Hybrid (3 days onsite weekly); remote work may be considered on a case-by-case basis and with approval.

You will develop within the medical writing role, coordinate basic clinical and regulatory documents, participate in cross-functional meetings, and mentor junior teammates.

Qualifications

• Advanced degree preferred with pharmaceutical writing exposure.

Responsibilities

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

Skills

English proficiency

Team collaboration

Mentoring

Regulatory writing

Education

Master's degree in life sciences

PhD preferred

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

We are searching for the best talent for Medical Writer II, Regulatory Medical Writing to support Oncology within our Integrated Data Analytics & Reporting (IDAR) business

The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company.

Purpose:

• Develops within the medical writing role within the pharmaceutical industry.
• Works in a team environment and matrix.
• Performs routine tasks per established procedures.
• Gains knowledge and applies internal standards, regulatory, and publishing guidelines.
• With increasing skill, uses internal systems, tools, and processes.
• Writes and coordinates basic documents, preparing more complex documents (within the TA and across TAs) in accordance with experience level.
• Functions as a lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision.
• Participates in process working groups.

You will be responsible for:

• Writing and coordinating basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writing, contributing to, and/or coordinating low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performing document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participating in and may be leading cross-functional document planning and review meetings. Working in a team environment with some guidance while increasing independence for longer-term activities.
• Taking an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interacting with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.

In accordance with experience level:

• Guiding or training cross-functional team members on processes and best practices.
• Leading early- or late-stage compound writing teams with supervision, as required.
• Learning and adhering to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Regularly meeting with manager and mentors and attending departmental meetings.
• Attending cross-functional meetings as appropriate (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings).
• Completing all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintaining and applying knowledge of industry, company, and regulatory guidelines.
• Mentoring more junior staff on document planning, processes, content, or provide peer review.

Principal Relationships:

• Internal manager, other writers, cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the planning and preparation of clinical documents.
• External: May interact with or oversee the day-to-day work of contractors or external service providers as needed under close supervision. May collaborate with external partner company staff on codeveloped compounds.

Are you ready to join our team? Then please read further!

Qualifications / Requirements:

• A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (eg, Master’s degree, PhD, MD) preferred.
• At least 2 years of relevant pharmaceutical/scientific experience is required.
• A range of 2 to 4+ years of regulatory medical writing experience is required.
• 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 to build solid and positive relationships with cross‑functional team members.
• Demonstrated problem-solving skills.
• Strong attention to detail.
• Strong time management and project/process management skills.
• Demonstrated learning agility / gains experience in interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content with supervision.
• Emerging leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves basic problems independently and more complex problems with supervision.
• Develops and applies knowledge of regulatory guidance documents such as ICH requirements.
• Sound knowledge of Microsoft Office programs (eg, Microsoft Word, Excel, PowerPoint, Outlook).

Preferred Skills:

• Business Behavior
• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaboration
• Copy Editing
• Data Gathering and Analysis
• Data Savvy
• Document Management
• Industry Analysis
• Medical Affairs
• Medical Communications
• Problem Solving
• Process Oriented
• Proofreading
• Quality Standards
• Research Ethics