Medical Writer II, Oncology

United States - Requisition Number: R-080142

Canada- Requisition Number: R-081535

Belgium & Netherlands - Requisition Number: R-081529

Switzerland - Requisition Number: R-081537

United Kingdom - Requisition Number: R-081540

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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:

• Writes and coordinates basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writes, contributes to, and/or coordinates 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.
• Performs document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participates in and may lead cross-functional document planning and review meetings. Works in a team environment with some guidance while increasing independence for longer-term activities.
• Takes an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interacts 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:
  • guides or trains cross-functional team members on processes and best practices.
• leads early- or late-stage compound writing teams with supervision, as required.
• Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Regularly meets with manager and mentors and attends departmental meetings.
• Attends cross-functional meetings as appropriate (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings).
• Completes all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintains and applies knowledge of industry, company, and regulatory guidelines.
• Mentors more junior staff on document planning, processes, content, or provide peer review.

Qualifications / Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
• A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
• A minimum of 2 to 4+ years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed.
• Strong oral and written communication skills.
• Attention to detail.
• Ability to function in a team environment.
• Organizes time well.
• Demonstrates learning agility.
• Builds solid and productive relationships with cross-functional team members.
• 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.

Required Skills:

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