Senior Analyst, Regulatory Medical Writing - Immunology

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: 2506235426W

Europe/India - Requisition Number: R-002023

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, Regulatory Medical Writing - Immunology to be in US, Canada, Europe, or India.

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 document planning and review meetings. Interacts with cross-functional colleagues on document content and champions medical writing 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.

• Actively participates in or leads process working groups.

• Coaches or mentors more junior staff on document planning, processes, and content. Provides peer review as needed.

Qualifications / Requirements:

• A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

• At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of 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 all document types under general supervision.

• Proficiency in written and spoken English is essential, together with excellent oral and written communication skills.

• Strong attention to detail.

• Ability to collaborate with cross-functional global teams across time zones, requiring some flexibility in your daily routine.

• Builds productive relationships with cross-functional team members.

• Has 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.

• Organizes time well and demonstrates learning agility.

The anticipated base pay range for this position is $91,000 to $147,200 CAD.