Principal Medical Writing Scientist

il y a 1 jour

Beerse, Belgique Johnson & Johnson Temps plein

Janssen Research & Development, L.L.C., is recruiting for a Principal Medical Writing Scientist to join the Neuroscience Regulatory Medical Writing team located in Titusville, NJ, Raritan, NJ, Spring House, PA, Or EU J&J locations such as High Wycombe, England, Beerse, Belgium, Leiden, Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Key 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 Regulatory 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
- 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
- Provides input into functional tactics/strategy (eg, writing teams, process working groups)
- May actively participate in or lead process working groups

**Qualifications**

**Education**:

- A university/college degree is required
- An advanced degree (eg Masters, PhD, MD) is preferred

Experience and Skills:
Required:

- At least 6 years of relevant pharmaceutical/scientific experience
- At least 4 years of relevant clinical/regulatory medical writing experience
- Ability to 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
- Ability to write and coordinate basic and complex documents, independently when working within own Therapeutical Area (TA), and under supervision when working across TAs
- Excellent oral and written communication skills
- Attention to detail and organizes time well
- Ability to function and lead in a matrix team environment
- Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative)
- Excellent analytical skills and ability to resolves complex problems under supervision
- Demonstrates learning agility
- Ability to builds solid and productive relationships with cross-functional team members

The base pay range for this position is $101,000- $142,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

**Primary Location**
United States-New Jersey-Titusville-1125 Trenton Harbourton Road

**Other Locations**
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-London, North America-United States, Europe/Middle East/Africa-United Kingdom-England, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Netherlands

**Organization**
Janssen Research & Development, LLC (6084)

**Job Function**
R&D

**Requisition ID**
2206061276W

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