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Principal Medical Writer (AD)

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POST DATE 8/9/2016
END DATE 10/13/2016

Shire Pharmaceutical Lexington, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
12120BR
AJE Ref #
575821288
Location
Lexington, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Job Description
PRIMARY DUTIES::

The Principal Medical Writer (MW) is responsible for medical writing activities for a program or multiple programs depending on the scope and stage of clinical development. With minimal oversight, provides strategic direction to cross-functional project teams to ensure that clinical documents (eg, investigators brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. The Principal MW writes and/or provides project/MW direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and accurate data presentation and interpretation.

In addition to project responsibilities, the Principal MW is responsible for a non-project related activity (eg, subject matter expert for a MW process). Generally leads or participates on departmental or cross-functional initiatives designed to establish best practices and efficient cross-functional collaboration.

The Principal Medical Writer reports to a Medical Writing Group Lead (Director level).

RESPONSIBILITIES:
50%:
Writing, most often the more strategic documents to support the goals of the product(s)/program(s).
35%:
Overseeing the medical writing aspects of the program(s), attending strategic meetings, developing timelines, assessing resource needs, collaborating with cross-functional colleagues
15%:
Leading or participating in departmental or cross-functional projects including process improvement initiatives and serving as a subject matter expert.

EDUCATION AND EXPERIENCE REQUIREMENTS:

Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor s degree required.
8+ years experience in clinical/pharmaceutical development with directly related medical writing experience.
Global regulatory submission experience required.

OTHER JOB REQUIREMENTS::

Less than 5% travel (domestic or international)

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.