At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at https://www.jnj.com
Job Function:
Medical Affairs Group
Job Sub Function:
Medical Writing
Job Category:
Professional
All Job Posting Locations:
Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Mechelen, Antwerp, Belgium, Spring House, Pennsylvania, United States of America, Toronto, Ontario, Canada
Job Description:
About Innovative Medicine
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 an Analyst II, Medical Writing to be in the United States, Europe and Canada.
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):
Switzerland - Requisition Number: R-019158
Belgium - Requisition Number: R-019164
United Kingdom - Requisition Number: R-019168
Canada - Requisition Number: R-019170
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:
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:
Education and Experience 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 0 to 4+ years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed.
Other:
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.
The expected pay range for this position is $89,000 to $143,750.
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.
Employees and/or eligible dependents may be 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.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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.
This job posting is anticipated to close on June 23, 2025. 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 anticipated base pay range for this position is :
$89,000-$143,750
Additional Description for Pay Transparency:
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. Employees and/or eligible dependents may be 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. Employees may be 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. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits 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.