Shire Lead Medical Writer in Lexington, Massachusetts
% of Time
Job Function and Description
- Leading the MW activities for assigned project(s) including writing key deliverables.
- Leading or participating on non-project related initiatives
Education and Experience Requirements
Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree required.
5-7 years experience in clinical/pharmaceutical development with directly related medical writing experience.
Global regulatory submission experience preferred.
Key Skills, Abilities, and Competencies
Ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
Ability, with some oversight, to lead the development, review, and approval of all clinical document types (ie, those typically developed by MW)
Basic project management skills including understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups
Ability to manage work timelines within assigned program(s).
Strong written presentation skills and ability to present information to others
Effective oral presentation skills (ie, ability to effectively lead a meeting and present issues)
Ability to interact effectively with team members/leaders
Ability to assess issues and develop potential solutions
Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (eg, GCP)
Working knowledge of the regulatory guidances regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs)
Strong knowledge of MS Word (required), Excel (preferred), Project (preferred), Powerpoint (preferred), and Outlook.
Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types.
Complexity and Problem Solving
Ability to multitask and work under time constraints
Ability to work on complex problems in which analysis situations require in-depth evaluation of various factors and resulting in solutions.
Other Job Requirements
- Less than 5% travel
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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 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.
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/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.