Manager, Scientific Writing

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Job description

Regeneron is seeking a highly motivated Manager, Scientific Writing to supervise regulatory submission drafting activities for preclinical pharmacokinetics (PK) content with a focus on genetic medicines, eg, siRNA and gene therapy products. In this role, you will develop and manage a team of PK writers within Regenerons Scientific Writing group, which overall is dedicated to the drafting of submission documents with nonclinical content (PK, Toxicology, and Pharmacology) as well as select documents supporting CMC and Clinical Pharmacometrics content.

A Typical Day Looks Like:

• Coach writers on preparation of regulatory submission documents with PPK content with a focus on genetics medicine throughout the entire document life cycle including content development, drafting, reviews, comment reconciliation, quality control, formatting, adherence to style guides, approval, and upload to file repositories.
• Develop processes and guidance documents for preclinical PK submission content (including Toxicokinetics) for emerging genetic medicine modalities in collaboration with the PK Subject Matter experts, Regulatory Affairs, and other relevant stakeholders.
• Manage team of writers, assign deliverables, and ensure regulatory compliance.
• Participate in relevant cross-functional meetings to ensure adherence to overall submission timing and strategy.
• Work together with other line managers within the Scientific Writing team, in particular your counterpart managing PPK for Protein Therapeutics, to ensure consistency in messaging, language, and quality across nonclinical content.
• Provide training and support professional development of direct reports and other mentees.

This Role May be For You If:

• You have extensive experience in regulatory submission drafting and thus an excellent understanding of the eCTD and of drug development
• You are skilled in taking initiative and working independently across multiple areas.
• You can collaborate effectively and provide mentorship to others in a multifaceted environment with ambiguity.
• You are an expert at attention to detail and in crafting language to distill scientific and regulatory key messages from source materials.
• You have a strong understanding of PK as it pertains to drug development and at least basic knowledge of genetic medicines (siRNA/gene therapy)

To be considered for this role, you must have a minimum of an MS degree in a Life Science with 7+ years in regulatory submission drafting (or similar relevant industry experience) and 2+ years of experience as a direct manager of people.

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)

$124,200.00 - $202,800.00

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