Principal Medical Writing Scientist

**Principal Medical Writing Scientist**:
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

**Position Summary**:

- Able to write and coordinate basic and complex documents, independently when working within own 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.
- May actively participate in or lead 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.Principal Responsibilities:

- 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.
- May actively participate in or lead 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.

**Qualifications**
**Education and Experience Requirements**:

- A university/college degree is required. An advanced degree (eg Masters, PhD, MD) is preferred.
- Extensive relevant pharmaceutical/scientific experience is required.
- Demonstrable 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.

**Who We Are**:
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

**Primary Location**
United Kingdom-England-High Wycombe
- **Other Locations**
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Belgium-Antwerp-Turnhout, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Poland
**Organization**
Janssen