Sr Scientific Writing Specialist

Regeneron Pharmaceuticals, Inc; United States; On-site; USD 94,000 - 153,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Sr. Scientific Writing Specialist to draft and manage reviews for Clinical Bioanalysis and Clinical Pharmacology submission documents across multiple therapeutic areas and all phases of clinical development.

You will lead document meetings, collaborate with cross-functional program teams, and contribute to digital technology-based solutions that streamline content creation and daily workflows, impacting patients worldwide.

Qualifications

• BS or higher in life sciences with 2+ years of relevant experience.
• Experience drafting and reviewing clinical submission documents.
• Strong attention to detail and written/oral communication.

Responsibilities

• Draft and manage reviews for Clinical Pharmacology and Clinical Bioanalysis documents.
• Lead kickoff and reconciliation meetings with cross-functional teams.
• Attend cross-functional program meetings and report relevant information.
• Manage multiple projects and timelines.
• Ensure data outputs align with stylistic standards and templates.
• Identify digital solutions to streamline content creation.

Skills

Scientific writing

Project management

Cross-functional collaboration

Attention to detail

Communication skills

Digital tools (AI/Automation)

Education

BS in life sciences

MS/PhD/PharmD in life sciences

Tools

Word

Excel

Adobe Acrobat

eCTD knowledge

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. Scientific Writing Specialist to draft and manage reviews for Clinical Bioanalysis and Clinical Pharmacology submission documents across multiple therapeutic target areas (Cardiovascular & Metabolism, Oncology, General Medicine, Immunology & Inflammation, Genetic Medicine) and all phases of clinical development (Phase 1 through Phase 3). In this role, you will lead document meetings and timelines while collaborating with cross-functional program teams, with the opportunity to contribute to digital technology-based solutions for content generation.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: [Insert location]
• Work model/flexibility: [Insert work model]

Discover your role:

• Independently draft and manage review of reports and summaries for the Clinical Pharmacology and Clinical Bioanalysis functional areas
• Lead Kickoff, Author, and Comment Reconciliation meetings for assigned documents
• Attend cross-functional program meetings and report relevant strategic information back to the writing team and management
• Manage multiple projects and timelines
• Review data outputs for consistency with stylistic standards
• Participate in the revision and maintenance of document templates or shells
• Bring strong attention to detail and excellent interpersonal and communication skills
• Stay curious about digital technology-based solutions that streamline content creation and daily workflows

This role requires:

• BS degree with 2+ years of relevant experience, or MS/PhD/PharmD in a life science
• 1-2 years of relevant industry experience in a biotech/pharma setting
• Strong attention to detail
• Excellent interpersonal and communication skills (verbal and written)
• Computer proficiency (Word, Excel, Adobe, and related software) and fluency in English
• Preferred: experience using digital technology-based solutions (e.g., AI, PerfectIt) to streamline content creation or workflows
• Preferred: basic understanding of the eCTD and drug development process
• Preferred: strong background in protein therapeutics and/or gene therapy

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$93,900.00 - $153,300.00