Summary
Seasoned individual contributor, who works independently with minimal supervision.Provides operational expertise in medical writing and vendor quality standards, partnering with internal and external groups to provide operational support and to ensure, compliance, and promote innovation in reporting deliverables. Formats, proofs, and completes documents, including but not limited to clinical protocols, clinical study reports, and investigator's brochures. Establishes document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
Description
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 GroupJob Sub Function:
Medical WritingJob Category:
ProfessionalAll Job Posting Locations:
CA003 ON Toronto - 19 Green Belt DrJob 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
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):
US - Requisition Number: 2506232322W
Europe - Requisition Number: R-001291
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
We are searching for the best talent for Senior Analyst, Oncology Medical Writing to be in North America, Europe, or other global locations.
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:
Writes or coordinates clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
Leads cross-functional (eg, with clinical team) document planning and review meetings. 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.
Completes 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).
Coaches or mentors more junior staff on document planning, processes, and content. Provides peer review as needed.
Actively participates in or leads process working groups.
Qualifications / 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 experience is required.
At least 4 years of relevant clinical/regulatory medical writing experience is required.
Recognizes 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.
Excellent oral and written communication skills.
Attention to detail.
Ability to function in a team environment.
Organizes time well.
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.
Demonstrates learning agility.
Builds solid and productive relationships with cross-functional team members.
The anticipated base pay range for this position is $95,000 to $152,950 CAD.
The anticipated base pay range for this position is :
95000 to 152950Additional Description for Pay Transparency:
