What are the responsibilities and job description for the Regeneron is hiring: Manager, Scientific Writing in Village of Tarrytown position at Regeneron?
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, e.g., siRNA and gene therapy products. In this role, you will develop and manage a team of PK writers within Regeneron’s 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 PK content focusing on genetic 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 a 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, particularly your counterpart managing PK 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 :
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.
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.
Salary Range (annually) $124,200.00 - $202,800.00
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Salary : $124,200 - $202,800
