Senior Medical Writing Scientist
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in cancers, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Motivated by our dedication to patients, we bring creative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. We are now looking for a Medical Writing Scientist or Senior Medical Writing Scientist to join our team.
Please visit www.janssen.co.uk for more information.
Summary of the Role:
As a (Senior) Medical Writing Scientist, you will apply good scientific writing and project management skills to support the development of documentation used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. You will work across therapeutic areas, principally supporting regional and global medical affairs research, working both independently and closely with various project teams to draft, coordinate and drive the completion of clinical and regulatory documents. You will be a go-getter who enjoys scientific writing and is now looking for a fresh challenge, either as their first step into regulatory medical writing or, ideally, as the second step in their career.
Principal Responsibilities:
- Prepares and finalizes clinical documents such as, but not limited to, clinical study reports and appendices, protocols and protocol amendments, less complex summary documents, and regulatory responses. Documents will be of good quality in terms of scientific content, organization per regulatory and internal guidance, clarity and accuracy, with keen attention to consistency and format.
- You may lead cross-functional document planning and review meetings.
- You will be Working in a team environment with greater independence for longer-term activities and takes an active role on assigned projects with respect to timing, scheduling, and tracking.
- Setting your own schedule for completing project-related tasks with less supervision and performs more complex tasks and process improvements.
- You are able to guide or train cross-functional colleagues on processes, standard methodologies; coach or mentor more junior writers.
If a Lead Writer, your principal responsibilities would include:
- Being the primary point of contact for Clinical/Global Program Team(s) for medical writing activities.
- Responsible for functional planning (as needed, with management mentorship) and metrics database updates for assigned program(s).
- Having Responsibility for cultivating regulatory medical writing standards and processes/methodologies on assigned program(s).
Qualifications Education and experience requirements:
A university/college degree is required, preferably in life sciences, plus good relevant pharmaceutical/scientific experience. An advanced degree (e.g. Masters, PhD, MD) would be beneficial.
Relevant scientific writing experience, which could be publications (e.g., from pharmaceutical and/or academic research) is required.
As a Senior Medical Writing Scientist within Janssen, you will demonstrate the following qualities and characteristics:
- Strong oral and written communication skills.
- Attention to detail.
- Flexible and adaptable approach to document development.
- Ability to function independently and potentially lead in a team environment.
- Self-motivated and organizes time well.
- Demonstrates learning agility.
- Builds solid and positive relationships with cross-functional team members.
- Basic project management skills.
- Basic leadership skills (influencing, negotiating, assertiveness, taking initiative).
- Learns and applies knowledge of regulatory guidance such as ICH requirements.
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.