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Senior Technical Writer, Medical Device

Lexington, Massachusetts

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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Senior Technical Writer, Medical Device

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Job ID SR0050488 Date posted 07/13/2020 Location Lexington, Massachusetts

Under the direction of the line manager and DDLs, the  Sr. Technical Writer, Medical Device is responsible for preparation of high quality device/combination product regulatory submissions and a wide range of supporting documentation across the device development lifecycle including pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, Briefing Books, Post- Approval changes or compliance updates across all global franchises.

In addition, the Senior Technical Writer is also expected to drive, support and contribute to broader improvement initiatives that contribute to Takeda’s overall success.

Job Function and Description

  • Perform device and pharmaceutical sciences technical writing and editing assignments related to the preparation of device/combination product components of regulatory submissions (eg. IMPD/CTA/IND, NDA, MAA, BLA, JNDA and Agency request for information, Briefing Books, Post- Approval changes or compliance updates across all global franchises).
  • Perform device and pharmaceutical sciences technical writing and editing assignments related to the preparation of device/combination product technical documents such as protocols, reports and procedures, as well as any other documents determined to be within the scope of the role.
  • On occasion the technical writer will participate in the development, implementation and maintenance of Takeda policies, guidelines and procedures that pertain to the preparation of combination and device regulatory submissions to ensure compliance with current regulatory expectations and alignment with associated Takeda systems.
  • Work cooperatively with colleagues in applicable functions or departments and external organizations (e.g., CMO) to ensure achievement of Takeda’s objectives relating to the preparation of device and combination product regulatory submissions and associated activities.
  • Perform device and pharmaceutical sciences technical writing and editing assignments related to the preparation of device/combination product components of regulatory submissions (eg. IMPD/CTA/IND, NDA, MAA, BLA, JNDA and Agency request for information, Briefing Books, Post- Approval changes or compliance updates across all global franchises).
  • Perform device and pharmaceutical sciences technical writing and editing assignments related to the preparation of device/combination product technical documents such as protocols, reports and procedures, as well as any other documents determined to be within the scope of the role.
  • On occasion the technical writer will participate in the development, implementation and maintenance of Takeda policies, guidelines and procedures that pertain to the preparation of combination and device regulatory submissions to ensure compliance with current regulatory expectations and alignment with associated Takeda systems.
  • Work cooperatively with colleagues in applicable functions or departments and external organizations (e.g., CMO) to ensure achievement of Takeda’s objectives relating to the preparation of device and combination product regulatory submissions and associated activities.
  • Develop and maintain knowledge and expertise in device and pharmaceutical sciences with an understanding of phase-related expectations throughout the lifecycle of device and combination product development.
  • Supports and facilitates writing of publications and presentations for conferences. Ensures compliance with company policies and acts as interface to relevant functions to obtain clearance in time to allow knowledge sharing with external community.
  • Organization support and project team participation including strategy meetings, information gathering, progress reports and presentations etc.
  • Actively contributes as medical device technical writer representative in cross functional settings
  • Proactively seeks input, feedback and assessment from key stakeholders to drive business improvements
  • Assists in the development and implementations of departmental processes, procedures and policies.
  • Active promoter of talent, knowledge sharing and collaborative spirit.
  • Experience in writing medical device and/or CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other major geographic areas is essential.

Key Skills, Abilities, and Competencies

  • Thorough knowledge and understanding of global requirements and expectations relating to medical device and/or CMC content of regulatory submissions throughout the lifecycle of drug development
  • Knowledge of medical device and combination product (for both biologics and chemically synthesized products) development
  • Detail oriented and articulate with ability to write in a precise, clear style
  • Excellent communication skills, written and verbal
  • Excellent organization skills
  • Strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgment
  • Proficient in use of Windows environment software with advanced skills in Microsoft Word

Education and Experience Requirements

  • Bachelor’s degree in Engineering, Biology, Chemistry, Pharmacy, or closely related field is required.
  • Advanced degree in Engineering, Biology, Chemistry, Pharmacy, or closely related field is desirable.
  • Minimum 10-15 years’ experience in the Pharmaceutical Industry, or relevant Regulatory environment.

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.

Job ID SR0050488

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