Senior Director, Medical Writing job in Boston, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Job type: Permanent

Discipline: Medical Writing, Account Management, Project Management

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Director, Medical Writing based in Boston, MA. This individual will be responsible for the management, oversight, operation, and direction of a larger group within the department. This role may be responsible for multiple programs and/or disease areas, as well as a key stakeholder working with cross-functional teams to provide scientific, clinical, and strategic input throughout the lifecycle of an asset.

Job Responsibilities:

Oversight of Medical Writing team responsible for the development of clinical and regulatory documents across the lifecycle of an asset
* Provides scientific, clinical, and strategic input for an asset(s) in clinical development within a portfolio for one or more disease areas
* Contributes strategic input to global marketing authorization applications and responses to health and regulatory authorities
* Leads internal governance bodies with high cross-functional impact (e.g., Protocol Governance Committee)
* Represents Medical Writing Science in Inspection Readiness and participates in GCP Audits and Inspections
* Mentors staff on professional development, motivates personnel, and resolves conflicts
* Oversee resource plans for programs within their oversight ensuring appropriate staff are available to meet program goals
* Advises on optimizing process improvements for the department
* Plans strategically, anticipates problems, and recommends process improvements to address current and future needs

Skills and Requirements:

Robust understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissions
* Robust understanding of disciplines beyond their discipline
* Distinguished record of developing, communicating, and executing strategic direction for projects
* Effective leadership skills with ability to influence at higher levels
* Excellent written and oral communication skills
* Ability to manage teams and individuals
Education and Experience:
* Bachelor's degree in relevant discipline
* Ph.D. (or equivalent degree)
* Typically requires 12 years of work experience and 5 years of supervisory/management experience, or the equivalent combination of education and experience

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323-306-2409 or m.hermiz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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