Senior Analyst, Oncology Regulatory Medical Writing

Senior Analyst, Oncology Regulatory Medical Writing

At Johnson & Johnson Innovative Medicine (IM), what matters most is helping people live full and healthy lives.

We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

IM Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.

Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team are recruiting for a Senior Analyst Regulatory Medical Writing to support our Oncology therapeutic area.

The position may be located in the US, UK, other European countries, or Canada.

R e mote work options may be considered on a case-by-case basis and if approved by the company.

Are you ready to join our team? Then please read further!

Key Responsibilities:


* Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.


* Lead cross-functional document planning and review meetings.

Interact with peer writers and colleagues from other departments.

Able to lead program-level or submission writing teams with supervision.

Able to lead process working groups.


* Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.

• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.

• If a lead writer for a program: Be the primary point of contact and champion for medical writing activities for the clinical team.

Responsible for planning, setting strategy, and leading writing group for assigned program.

• Maintain and apply knowledge of the industry, company, and regulatory guidelines.

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.

Note: this is not a line-management position.

Education:

University/college degree required.

Masters or PhD preferred.
Experience and Skills:


* 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 strongly preferred.


* Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality ...