Posted to MedZilla on 9/17/2019


Takeda Pharmaceuticals

US-MA, Principal Medical Writer SR0040480-MZ


 
 

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

% of Time

Job Function and Description

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)

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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