Regeneron Pharmaceuticals Sr Medical Writer in Basking Ridge, New Jersey
The Senior Medical Writer will be responsible for supervising their own writing projects, and for knowing, understanding, and ensuring adherence to regulatory guidelines and department document standards. We expect them to ensure maintenance of document standardization through use of model documents/templates and appropriate peer review. We assume the writer to review documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR. The Senior Medical Writer will be responsible for liaising with the appropriate matrixed team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion. The individual in this position will work independently writing CSRs, CSPs, CSP amendments, and ICFs in a variety of therapeutic areas. Training on Clinical Summaries and other regulatory documents may be provided.
In this role, a typical day might include the following:
Working with the clinical team, the Senior Medical Writer will be responsible for writing Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Informed Consent Forms, and Patient Safety Narratives. Opportunities to write or contribute to other Regulatory documents such as Clinical Summaries and Briefing Documents may be provided.
Represent medical Writing at cross-company and TA meetings.
Drive document development meetings;
Articulate document strategy and timelines;
Be able to identify the correct parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss.
Follow a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
Manage processes and organize priorities; Solve problems; Foster collaboration to resolve conflict
Experience writing in plain language style (for ICFs)
Ability to explain complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience
Familiarity with ICH GCP guidelines for informed consent considered a plus
This role might be for you if:
You Have the ability to work independently
You can provide appropriate input on others’ documents, including review of key contributing documents, such as the SAP
You are able to proactively identify and manage projects, requiring some but not significant guidance
You can comprehend key points of meetings and interactions, and follows up when necessary
To be consider, we expect you to have 5+ years of medical writing experience along with a bachelors degree. We expect the medical writer to have written CSRs, clinical protocols, clinical protocol amendments, patient narratives, and ICFs.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.