Johnson & Johnson Careers
Principal Medical Writing Scientist
Requisition ID: 2259180524
Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Principal Medical Writing Scientist position to be located in Spring House, PA; Titusville, NJ; or Raritan, NJ with up to 10% domestic travel.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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. And we pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Bring your talents to our mission, visit http://www.janssenrnd.com to learn more.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Principal Medical Writing Scientist:
- Prepares and finalizes clinical documents such as, but not limited to, Clinical Study Report (CSR) and appendices, Investigators Brochure (IB)s, protocols and protocol amendments, summary documents, Risk Management Plan (RMP) (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 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.
- Prepares basic and complex documents (within the therapeutic area [TA]) (see examples under "principal responsibilities") independently and across TAs under supervision.
- Provides input into functional tactics/strategy (eg, writing teams, process working groups).
- Leads cross-functional document planning and review meetings.
- 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.
- Applies internal standards, regulatory, and publishing guidelines.
- Highly proficient in the use of internal systems, tools, and processes.
- Able to function as a lead writer on most compounds under supervision.
- Actively participates or leads process working groups.
- Able to lead compound/submission/indication/disease DAS writing teams with supervision.
- 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.
- Responsible for establishing document timelines and strategies in accordance with internal processes, with some guidance from functional management and clinical team, as needed.
- Resolves complex problems under supervision.
- Regularly meets with manager and mentors, and attends departmental meetings.
- Attends cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
- Maintains and applies knowledge of industry, company, and regulatory guidelines.
- May actively participate or lead on process working groups.
- Completes all time reporting, training, metrics database, and project tracking updates as required.
- Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.
- A Bachelor’s Degree or University Equivalent and at least 6 years in relevant pharmaceutical/scientific experience is required
- An advanced degree (eg, Masters, PhD, MD) is preferred
- At least 4 years of relevant regulatory medical writing experience is required
- Effective leadership skills and proven ability to foster team productivity in a cross-functional environment is required
- Strong organization and prioritization skills with a demonstrated ability to work in a fast-paced, rapidly changing environment is required
- Proven learning agility with the ability to quickly assimilate and apply knowledge is required
- Strong project management skills are required
- Strong project and process leadership skills are highly preferred
- Solid knowledge and application of regulatory guidance documents such as ICH requirements is required
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)