(Senior) Medical Writing Scientist
Locations: Beerse, Belgium
Functions: Medical Writing
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Requisition ID: 1905773021W
The Medical Writing Scientist:
* Learns the medical writing role and pharmaceutical industry and business.
* Learns and works in a team environment and matrix.
* Learns and applies internal standards, regulatory, and publishing guidelines.
* Learns and uses with increasing skill, internal systems, tools, and processes.
* Able to prepare basic documents and sections of more complex documents (within the therapeutic area [TA]) (see examples under "principal responsibilities") under close supervision (is closely trained/coached by a senior-level writer or manager).
* Performs routine tasks per established procedures (see examples under "principal responsibilities").
* Prepares basic clinical documents under close supervision such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, protocol amendments, initial IBs, IB addenda. 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.
* Helps prepare sections of more complex clinical documents under close supervision (eg, IB updates, Phase 2/3 CSRs and appendices, RMP annexes, protocol T&E schedules).
* Performs document QC, abbreviations, references, literature searches, table creation, and other basic tasks with some supervision.
* Participates in cross-functional document planning and review meetings.
* Works in a team environment with some guidance provided, and takes a somewhat active role (under close supervision) on assigned projects with respect to timing, scheduling, and tracking.
* Learns how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content, under close supervision.
* Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide.
* Regularly meets with manager and mentors, and attends departmental meetings.
* Attends cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).
* Completes all time reporting, training, and metrics database updates as required.
Functional Contacts Inside the Company (as collaborator and peer): manager, peer writers. Peer employees from other departments such as Global Clinical Development Operations, Quantitative Sciences, BioResearch Quality & Compliance; External Alliances; TA staff (Clinical), Regulatory Affairs, GMS, PMO, Clin Pharm, etc.
May interact with contractors or external service providers as needed, under close supervision.
A university/college degree is required plus at least 2 years in relevant pharmaceutical/scientific experience. An advanced degree (eg, Masters, PhD, MD) is preferred.
QUALITIES AND CHARACTERISTICS:
* Solid oral and written communication skills.
* Attention to detail.
* Ability to function in a team environment.
* Organizes time well.
* Demonstrates learning agility.
* Builds solid and productive relationships with cross-functional team members.
What's in it for you…?
"Caring for the world, one person at a time…"
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)