Johnson & Johnson Careers
Principal Medical Writing Scientist
Requisition ID: 1905735418W
"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
Actelion is a leader in the field of pulmonary hypertension (PH). Our portfolio of PH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming 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 collaborate with the world for the health of everyone in it.
Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a:
Principal Medical Writing Scientist
- Prepares and finalizes clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, summary documents, RMPs (initial and updates), regulatory responses, and briefing documents. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
- Leads cross-functional document planning and review meetings.
- Leads in a team environment with greater independence for longer-term activities, and takes a lead role on assigned projects with respect to timing, scheduling, and tracking.
- Indirectly or directly leads or sets objectives for others on team projects and tasks; eg, able to lead process working groups.
- Guides or trains cross-functional team members on processes, best practices; coaches or mentors more junior writers.
- Able to lead compound/submission/indication/DAS writing teams with supervision.
- If a Lead Writer, principal responsibilities include, but are not limited to:
- Primary point of contact for Clinical/Global Program Team for medical writing activities.
- Responsible for functional planning and metrics database updates for assigned program.
- Responsible for championing RegMW best practices on assigned program.
- Responsible for setting strategy and leading writing group on various projects.
- A university/college degree is required plus at least 6 years in relevant pharmaceutical/scientific experience. An advanced degree (eg, Masters, PhD, MD) is preferred.
- At least 4 years of relevant regulatory medical writing experience is required.
- Excellent oral and written communication skills.
- Attention to detail.
- Ability to function (and potentially lead) in a team environment.
- Organizes time well.
- Demonstrates learning agility.
- Builds solid and productive relationships with cross-functional team members.
- Strong project management skills, strong project/process leadership.
- Strong leadership skills (influencing, negotiating, assertiveness, taking initiative).
If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your online application by clicking here.
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)