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Associate Director, Clinical Regulatory Writing (Hybrid)

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Wednesday, January 24, 2024

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 market.

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.

Key Duties and Responsibilities:

  • Independently authors routine and complex clinical and regulatory documents
  • Provides strategic input into program-level plans
  • Deep insight into how different functions contribute to the successes of the team
  • Aligns, coordinates, and builds consistent information and messages across clinical program(s)
  • 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

Knowledge and Skills:

  • Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives
  • Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues
  • Proven track record of anticipating potential problems and preparing contingency plans as needed
  • Understanding of scientific disciplines beyond own specialty area
  • Experience managing direct reports and guiding staff development
  • Experience with marketing authorization application regulatory submissions

Education and Experience:

  • Ph.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

Pay Range 157,600.00 - 236,400.00 USD annually

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.



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