Medical Writing Science Senior Manager (Hybrid)

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 137,000 - 206,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Vertex Pharmaceuticals Inc in Boston is seeking a Medical Writing Science Senior Manager to independently author complex clinical study documents and portions of regulatory submissions across development stages. This hybrid role allows 2 days remote and 3 days in the Boston Fan Pier office.

You will lead regulatory writing for pivotal studies, mentor teams, and contribute to regulatory strategy, while ensuring compliance with company standards and industry guidelines.

Qualifications

• Author comprehensive clinical regulatory documents in line with regulatory standards.
• Lead writing for complex/pivotal studies across programs.
• Review and ensure regulatory documents meet quality and compliance.

Responsibilities

• Author complex clinical regulatory documents with stakeholders.
• Lead Medical Writing Scientist for pivotal studies across programs.
• Provide expert review of study-level and program-level documents.
• Contribute to regulatory strategy and key messaging for regulatory submissions.
• Prepare and support content for advisory committee presentations and briefing documents.
• Help develop SOPs, processes, and tools in cross-functional teams.

Skills

Regulatory writing

Cross-functional leadership

Scientific writing and editing

Regulatory strategy

Project management

Education

Bachelor's degree in relevant discipline

Ph.D. (or equivalent degree)

Job description

Job Description General Summary:

The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. This role may represent Medical Writing Science as a cross-functional team member for study-level and program-level activities. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office.

Key Duties and Responsibilities:

Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas Provides expert review of study-level and program-level documents Participates in developing key messages for complex clinical regulatory documents Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents Ensures document preparation is compliant with company and industry standards Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies

Knowledge and Skills:

Outstanding written and oral communication skills Extensive experience writing and editing clinical regulatory documents Ability to analyze, interpret, and summarize highly complex data Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology Ability to mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions Highly developed project management and organizational skills Ability to manage challenging, high-value projects Initiative and creativity in solving complex problems; ability to have a substantial role in developing and implementing improvements in cross-functional processes

Education and Experience:

Bachelor's degree in relevant discipline Ph.D. (or equivalent degree) Typically requires 6 years of experience or the equivalent combination of education and experience. #LI-AR1 #LI-Hybrid

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$137,200 - $205,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid

Company Information:

Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [e-mail]

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.