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Associate Director, Medical Writer

2 months ago

Cambridge, United States Blueprint Medicines Full time

How will your role help us transform hope into reality?



Please read the following job description thoroughly to ensure you are the right fit for this role before applying.

The Associate Director (MW) is responsible for clinical strategic document expertise across the global regulatory marketed and development portfolio. You will support and guide all clinical regulatory documents to be included in eCTD submissions and other global health authority (HA) submission types, including all original applications, information requests, amendments, responses, and all other clinical submission types. You will supervise regulatory writing vendors to manage submission documents and ensure the science-supported clinical messaging is clear and concise and is fully aligned with program team strategy. You will collaborate with cross functional teams providing timelines and overall medical writing document management activities. You will provide regulatory system and authoring template assessments to further develop and enhance the regulatory writing processes, deliver high-quality submission-ready documents to contribute to Blueprint Medicines overall company objectives.



 



What will you do?




  • Lead the MW function across the company portfolio (marketed products and development programs) to build cross-functional relationships to improve efficiency, sustainability and the progression of Blueprint Medicines clinical programs and overall business objectives.
  • Build and manage a medical writing function to supervise all global clinical and regulatory authoring activities, MW project management, document timeline knowledge and effective communication across the portfolio to ensure accurate and timely delivery of clinical and regulatory documents to global health authorities.
  • Collaborate cross-functionally with department heads, document leads, and subject matter experts (SMEs) across the business (ex., Clinical Research, Medical Affairs, Clinical Operations, Pharmacovigilance, Clinical Pharmacology, etc.) to prepare a compelling, consistent, high-quality, clinical regulatory messaged documents grounded in science and fluent with global regulations.
  • Understand clinical data, information, references, and other sources to lead and align with document authors and program teams to prepare and present data and document messaging consistent with regulatory requirements, guidelines, and program strategy.
  • Coordinate and lead document roundtables, reviews, approvals, quality control (QC) and other document content issues and overall questions during the authoring process, including technical troubleshooting as needed.
  • Communicate with leadership, stakeholders and SMEs regarding document timelines, milestone progress and resources (as needed) throughout the duration of the document lifecycle/submission/program.
  • Identify, develop, and implement new standard operating procedures (SOPs), work instructions (WIs) and various convention and style guides to improve the overall regulatory authoring business process.


 



What minimum qualifications do we require?




  • A bachelor’s degree is required; relevant advanced degree (e.g., MS, PharmD, PhD, MD) is preferred
  • 7+ years of proven experience in medical/clinical/regulatory writing in the pharmaceutical/biotechnology/healthcare industry; academia experience is a plus
  • 3+ years of regulatory document project management oversight/experience


 



What additional qualifications will make you a stronger candidate?




  • Sophisticated content writing with direct experience with regulatory and clinical documents highly preferred
  • Original regulatory applications (IND, NDA/BLA, MAA, NDS, etc.) experience highly preferred
  • Solid understanding of statistical concepts and techniques including understanding of scientific content with the ability to interpret into final submission-ready documents
  • Advanced knowledge of US and international regulations, requirements, and guidance associated with scientific publications or regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations
  • Knowledge and expertise with Common Technical Document structure and content templates, electronic document management systems and information technology
  • Excellent working knowledge of software programs in Windows environment
  • Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism


 



Why Blueprint?



At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.



This is the place where the extraordinary becomes reality, and you could be part of it.



Patients are waiting. Are you ready to make the leap?



 



Equity, Diversity, Inclusion and Affirmative Action



At Blueprint Medicines, we foster a culture of equity, diversity and inclusion.  A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We are also an E-Verify Employer.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. 



For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement. 



 



Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.



 



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