Associate Director/Director, Medical - Boston, MA, United States - Vertex Pharmaceuticals

Description

Associate Director, Clinical Regulatory Writing (Hybrid) page is loaded Associate Director, Clinical Regulatory Writing (Hybrid)
Apply locations Boston, MA time type Full time posted on Posted 30+ Days Ago job requisition id REQ-20940 Job Description

At Vertex, our Clinical Regulatory Medical Writers are strategic scientific partners in the drug development process, collaborating with cross-functional teams to bring new, life-changing products to patients.

The Associate Director, Clinical Regulatory Medical Writing manages the overall operations of a team or major project and implements this through effective leadership.

This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements.

This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments.

Independently authors routine and complex clinical and regulatory documents
Provides leadership related to the activities of Medical Writing Science and manages a team
Participates in developing and implementing goals and initiatives for Medical Writing Science
Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents
Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements
Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives
Understanding of scientific disciplines beyond own specialty area
Experience managing direct reports and guiding staff development
Experience with marketing authorization application regulatory submissions
D. in a relevant field
Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience
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.

#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 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
Medical Writing Science Senior Manager (Hybrid)
locations Boston, MA time type Full time posted on Posted 30+ Days Ago Associate Director, Medical Publications (Remote)
locations Boston, MA time type Full time posted on Posted 30+ Days Ago Associate Director, Regulatory CMC, Cell Therapy Combination Product (Boston)

locations Boston, MA time type Full time posted on Posted Yesterday Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases.

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 APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is 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 14 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 or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths.