Medical Writer II, Oncology

Johnson & Johnson•Titusville, PA

4d•Hybrid

About The Position

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine 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 may be located Beerse, Belgium; Leiden,The Netherlands; High Wycombe/Maidenhead, UK; Toronto, Canada or Spring House / Titusville, United States. 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 As Medical Writer II, Regulatory Medical Writing, you will support our Oncology therapeutic area within our Regulatory Medical Writing team, to author diverse regulatory medical writing documents. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom- Requisition Number: R-096079 Belgium, Netherlands- Requisition Number: R-097258 United States - Requisition Number: R-097262 Canada - Requisition Number: R-097266 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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).

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 be leading 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.
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year