Job Function: Medical Affairs Group
Job Sub Function: Medical Writing
Job Category:Professional
All Job Posting Locations:Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
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 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.
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.
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).
Benefits
The expected pay range for this position is $92,000 - $148,35 USD.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
- Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
- Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- 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
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on September 9. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
