Senior Analyst, Oncology Regulatory Medical Writing
We believe health is everything at Johnson & Johnson. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured.
Job Function: Medical Affairs Group
Job Sub Function: Medical Writing
Job Category: Professional
All Job Posting Locations: Beerse, Belgium; Espoo, Finland; Helsinki, Finland; High Wycombe, UK; Issy-les-Moulineaux, France; Leiden, Netherlands; Little Island, Ireland; Madrid, Spain; Mechelen, Belgium; Tuttlingen, Germany; Warsaw, Poland
Job Description:
At Johnson & Johnson Innovative Medicine (IM), we focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our Research & Development team 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.
The Regulatory Medical Writing team is recruiting for a Senior Analyst Regulatory Medical Writing to support our Oncology therapeutic area. This position is located in the United Kingdom or alternatively, candidates may be located in Ireland, France, Belgium, Netherlands, Germany, Spain, Poland, or Finland.
Key Responsibilities:
* Prepare and finalize clinical documents such as 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.
* 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.
* 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 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.
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.
* Compound lead and/or submission lead experience is preferred.
* Proficiency in written and spoken English is essential.
* Able to build solid and positive relationships with cross-functional team members.
* Strong time and project/process management/leadership skills.
* Able to resolve complex problems.
* Demonstrate learning agility and mentoring competency.
* Strong attention to detail.
* Travel up to 10%.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process.