Johnson & Johnson Careers
senior medical writer
High Wycombe, United Kingdom
Requisition ID: 1805679839W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, 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. Please visit www.janssen.co.uk for more information.
As a Senior Medical Writing Scientist (SMWS), your key objectives will be:
- To learn the medical writing role within the pharmaceutical industry and business, working as part of a reciprocal team environment and matrix.
- Appling relevant internal standards, regulatory, and publishing guidelines, you will work towards becoming proficient in the use of internal systems, tools, and processes.
- You will develop the ability to prepare basic documents independently and more complex documents (within the therapeutic area [TA]) (see examples under "principal responsibilities") under direction. May prepare documents across TAs with mentorship.
- Growing within the role you will be given the responsibility to function as a lead writer on a project, indication, or a compound either early-or late-stage in life cycle with supervision or mentorship.
- May participate in process working groups.
- Prepares and finalizes clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, less complex summary documents, RMPs (initial and updates), and less complex regulatory responses. Documents should be of high quality in terms of scientific content, as well as organization per regulatory and internal mentorship, clarity, and accuracy, with attention to format and consistency.
- Leads cross-functional document planning and review meetings.
- Works 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.
- Sets their own day-to-day schedule for completing project-related tasks with less supervision and performs more complex tasks and process improvements.
- Able to guide or train cross-functional colleagues on processes, standard methodologies; coach or mentor more junior writers.
- May lead early- or late-stage compound writing teams with close supervision.
- Empowered as a Lead Writer, your principal responsibilities would include:
- Primary point of contact for Clinical/Global Program Team for medical writing activities.
- Responsible for functional planning (as needed, with management mentorship) and metrics database updates for assigned program.
- Responsible for cultivating RegMW standard methodologies on assigned program.
Education and experience requirements:
A university/college degree is required plus strong relevant pharmaceutical/scientific experience. An advanced degree (e.g. Masters, PhD, MD) would be beneficial.
Experience of relevant Pharmaceutical and/or Academic writing. This could be publications, e.g., from the pharma or academic research is a prerequisite.
As a SMWS within Janssen, you will demonstrate the following qualities and characteristics:
- Strong 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 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 documents such as ICH requirements.
Johnson and Johnson are an equal opportunity employer.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)