Medical Writer

Regeneron Pharmaceuticals • United States, United States • 1w ago

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to chip in to other regulatory documents may be provided. The SMW tracks their own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion.

As a Senior Medical Writer, a typical day may include:

Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided

Represents MW at meetings

Drives document development meetings

Articulates document strategy and timelines

Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss

Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly

Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development

Drives processes and coordinates priorities; solves problems; fosters collaboration to resolves conflict

May review the work of junior and outsourced MWs

May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion

Writes in plain language style as appropriate (eg, for ICFs)

Explains sophisticated medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience

May mentor junior staff

Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area

Remains aligned with internal training

To be considered for this role, you must have the following:

Education

Bachelor's degree (advanced degree preferred)

Experience

Minimum of 3 years of relevant MW experience including working knowledge of biostatistics.

Solid understanding of the clinical research process and regulations/guidelines

Clinical document reading, writing, and editing experience

Strong organizational, interpersonal and communication skills

Solid understanding of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems

Ability to manage multiple projects

Familiarity with ICH GCP guidelines

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the @type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$126,700.00 - $206,900.00

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