AD/Director Medical Writing job in Gaithersburg, USA

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Job type: Permanent

Discipline: Medical Writing, Media & Publishing, Project Management

Location: United States

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

Proclinical is seeking a remote AD/Director of Medical Writing for a leading biotech. As the Associate Director, you will be a key member of the Medical Writing Department responsible for the preparation, coordination, and review of clinical/regulatory documents in support of our clinical portfolio of innovative vaccines. This position is located at our Gaithersburg, MD office but for the right candidate we will consider remote (U.S. based) employee.

Job Responsibilities:

Preparing and reviewing complex clinical documents (eg, clinical study reports [CSRs], protocols, Investigator's Brochures [IBs], and Biologic License Application [BLA] clinical documentation).
Coordinating preparation of clinical documents for regulatory submissions.
Managing third-party vendors for medical writing deliverables.
Supporting clinical publications (manuscripts, abstracts, and poster presentations) and publication strategies.
Representing medical writing on cross-functional teams and leading medical writing initiatives within the organization.

Skills and Requirements:

Bachelor's Degree or higher, with minimum of five years medical writing experience.
Ability to lead meetings and interactions to ensure timely delivery of key submissions.
Lead author on multiple CSRs and/or protocols.
Excellent command of the English language, both oral and written, with strong scientific understanding.
Ability to manage work independently or in a collaborative setting in the context of crossfunctional teams.
Able to manage multiple priorities and adapt quickly to new situations and new project demands.
Experience with oversight of outsourcing.
Strong command of statistical concepts and techniques, and immunological detection methods.
Escalate conflict appropriately.
Strong command of FDA regulations, GCP guidelines, and industry recommendations for the conduct and reporting of clinical studies.
Expert in word processing (MS Word) and excellent working knowledge of software programs in Windows environment such as PowerPoint, Endnote and Adobe Acrobat.

Additional Skills/Preferences:

Previous vaccine experience preferred.
Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
Experience in ClinicalTrials.gov and EudraCT protocol registration/results posting.

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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