Medical Writer III, Oncology

Johnson & Johnson Innovative Medicine; Toronto; Ibrido; CAD 87.000 - 140.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson Innovative Medicine in Canada seeks a Medical Writer III, Regulatory Medical Writing to support Oncology within the Integrated Data Analytics & Reporting group. The role may be located Beerse, Leiden, High Wycombe/Maidenhead, Toronto or Spring House/Titusville, and is Hybrid (3 days onsite weekly).

Remote work may be considered case-by-case. Please note the role is posted across multiple countries to comply with local requirements.

Competenze

• University/college degree in a scientific discipline is required.
• At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience.
• Oncology therapeutic area experience is preferred.
• Ability to interpret, summarize, and present statistical and medical information for complex documents.
• Compound lead and/or submission lead experience is preferred.

Mansioni

• Write or coordinate clinical and regulatory documents such as CSRs, IBs, protocols, summaries, RMPs, regulatory responses, and briefing documents.
• Lead cross-functional document planning and review meetings with clinical teams.
• Maintain time reporting, training, and project-tracking in relevant systems.
• Function as lead writer on most compounds or submissions under supervision.
• Coach or mentor junior staff on document planning and content.

Conoscenze

Business Writing

Clinical Research and Regulations

Copy Editing

Data Synthesis

Formazione

Bachelor's degree in a scientific discipline

Advanced degree (Masters/PhD/MD) preferred

Descrizione del lavoro

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Toronto, Ontario, Canada

Job Description:

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 III, 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.

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: R-105516
• Belgium/Netherlands: R-105590
• United States: R-105615
• Canada: R-105619

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

Purpose:

• Able to write and coordinate basic and complex documents, independently when working within own therapeutic area (TA), and under supervision when working across TAs.
• Leads in a team environment and matrix.
• Able to function as a lead MW on most compounds, under supervision.
• Actively participates in or leads process working groups.
• Provides input into functional tactics/strategy (eg, writing teams, process working groups).
• Highly proficient in the use of internal systems, tools, and processes.

You will be responsible for:

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional (eg, with clinical team) document planning and review meetings. 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.
• Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
• Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision. Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coaching or mentoring more junior staff on document planning, processes, and content. Provides peer review as needed.
• Actively participating in or leads process working groups.

Principal Relationships:

• Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.
• External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.

Education and Experience Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
• At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience!
• Oncology therapeutic area experience is preferred.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.
• Compound lead and/or submission lead experience is preferred.
• Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine.
• Able to build solid and positive relationships with cross‐functional team members.
• Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
• Able to resolve complex problems under supervision.
• Demonstrate learning agility (self-development) and mentoring competency (development of others).
• Strong attention to detail.
• Builds solid and productive relationships with cross-functional team members.

Benefits

The expected base pay range for this position is $87,000 to $140,300 CAD.

The Company uses Artificial Intelligence in its assessment of applicants.

This job posting is for an existing position.

Ineligibility for severance.

Accessibility for Ontarians with Disabilities Act

Required Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

$87,000.00 - $140,300.00

Additional Description for Pay Transparency:

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits