Shire Technical Writer in Lexington, Massachusetts
Under the direction of the line manager, the Technical Writer is responsible for preparation of high quality regulatory submissions and a wide range of supporting documentation across the drug 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 Technical Writer will also be expected to drive, support and contribute to broader improvement initiatives that contribute to Shires overall success.
Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports and procedures, as well as any other documents determined to be within the scope of the role; and ensure that project time-lines are met
On occasion the technical writer will participate in the development, implementation and maintenance of Shire policies, guidelines and procedures that pertain to the preparation of CMC regulatory submissions to ensure compliance with current regulatory expectations and alignment with associated Shire systems
Work cooperatively with colleagues in applicable functions or departments (e.g., R&D, Process Development, Manufacturing, Supply Chain, Regulatory Affairs, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to ensure achievement of Shire objectives relating to the preparation of CMC regulatory submissions and associated activities
Develop and maintain knowledge and expertise in CMC with an understanding of phase-related expectations throughout the lifecycle of drug development
Organization support and project team participation including strategy meetings, information gathering, progress reports and presentations etc.
Actively contributes as CMC 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
Education and Experience
Bachelor’s degree in Chemistry, Chemical Engineering, Pharmacy, or closely related field is required
Advanced degree in Chemistry, Chemical Engineering, Pharmacy, or closely related field is desirable
Minimum 0-2 years (MS) or 2-5 years (BS) experience in the Pharmaceutical Industry, or relevant Regulatory environment
Experience in writing 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 CMC content of regulatory submissions throughout the lifecycle of drug development
Knowledge of drug development requirements for both biologics and chemically synthesized products, as well as devices and combination products
Ability to represent CMC Regulatory Submissions as a member of project teams
Technical consultant for the department on complex issues
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
Ability to assess need, apply experience and develop solutions to complex issues and to determine and/or negotiate the most appropriate course of action in a timely manner
Ability to engage and influence a range of personnel, peers, and superiors with a collaborative style
Drive and energy to multi-task in a fast-paced environment, with flexibility and strength to navigate through crises
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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.
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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire 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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.