Medical Writer II, Oncology

Johnson & Johnson Innovative Medicine

2d•$92,000 - $148,350•Hybrid

About The Position

This role is within the pharmaceutical industry, specifically in Medical Affairs, focusing on Medical Writing within the Oncology therapeutic area. The Medical Writer II will work in a team environment and matrix structure, performing routine tasks according to established procedures. They will gain knowledge and apply internal standards, regulatory, and publishing guidelines, utilizing internal systems, tools, and processes. The position involves writing and coordinating basic documents and preparing more complex documents as experience grows. The role functions as a lead writer on a project, indication, or compound, either early or late-stage in its lifecycle, under close supervision. Participation in process working groups is also expected.

Requirements

A university/college degree in a scientific discipline is required.
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.

Nice To Haves

An advanced degree (eg, Masters, PhD, MD) is preferred.

Responsibilities

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.

Benefits

medical
dental
vision
life insurance
short and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year