Director, Medical Writing
3 weeks ago
Empower the Future of Medicine at Alexion, AstraZeneca Rare Disease
Join our passionate team at Alexion and contribute to our mission of delivering life-transforming therapies to patients with rare diseases. We are seeking an experiencedDirector, Medical Writingto drive the creation of high-quality clinical regulatory documents and support the development of our clinical portfolio.
Your Impact:
As a pivotal member of our team, you will:
Strategize and Lead: Drive the development and execution of document strategies for regulatory submission, ensuring the highest quality of filing submission documents (Mod 2 Clinical Summaries, Clinical Overviews), clinical study protocols, reports, and Investigator's Brochures.
Collaborate and Contribute: Play a key role in developing briefing packages and responses to health authority inquiries, contributing to global regulatory submission documents.
Ensure Excellence: Author and run outstanding medical writing deliverables, guaranteeing scientific accuracy, clarity, and compliance with regulatory and internal guidelines.
Communicate Consistently: Support the development of uniform messaging across all submission documents, including nonclinical, clinical, and product labeling.
Mentor and Direct: Mentor and Direct medical writing team members to ensure efficiency and quality in document production.
Innovate and Collaborate: Develop effective partnerships within Alexion and with external team members to maintain adherence to industry standards and regulatory requirements.
What You Bring to the Table:
Experience: At least 10 years of clinical regulatory medical writing experience, with global clinical trials and regulatory submissions expertise.
Communication Skills: Exceptional oral and written communication abilities, with proficiency in MS Office.
Regulatory Knowledge: A deep understanding of global regulatory requirements and ICH/GCP guidelines.
Leadership: Proven experience leading and mentoring medical writers and fostering the development of junior staff.
Professional Ethics: A strong sense of responsibility, ethics, and respect for others.
Work Environment: Ability to work in an office environment, using computers and participating in communication and collaborative activities during standard business hours.
Preferred Qualifications:
Education: PhD or MS degree in life sciences or an advanced degree or equivalent experience in a relevant field.
Relationship Building: Outstanding skills in establishing internal and external relationships, including with alliance partners and vendors.
Project Management: Proficiency in planning, budgeting, and project management, coupled with strong problem-solving and negotiation skills.
Specialized Experience: Knowledge of rare and ultra-rare diseases is highly advantageous.
Drive and Excellence: A results-driven mindset with a dedication to high standards of excellence.
What we offer:
Flexible Health Benefits:a flexible benefits program for comprehensive health and dental care. Our extended benefits include prescription drugs, vision care, fertility treatment, support for gender affirmation procedures as well as other health and mental health options. We uphold work-life balance policies, and offer resources like Teledoc Health, giving employees and their families access to top medical experts.
Retirement Savings:Employees receive an automatic employer Pension contribution and can contribute to the Optional Savings Plan, which attracts an additional company match. Opportunities to contribute to a Stock Purchase Plan as well as a TFSA are also available.
Flexible Extras: We offer extras to support employees and the big moments in life. From great maternity, parental and adoption leave support, to increased paid bereavement days, and our 12-week top-up for conscientious and critical illness leave, we look after our people. We also encourage continuing education through employee tuition assistance support
Vacation:a minimum of 4 weeks of paid vacation, pro-rated to your date of hire.
Why Join Us?
At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
Ready to lead and inspire?
Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We align with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
#LI-Hybrid
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
#J-18808-Ljbffr-
Associate Director, Clinical Regulatory Writing
4 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada AstraZeneca GmbH Full timeJob DescriptionRole holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects.Typical AccountabilitiesThe Clinical Regulatory Writing team provides expert...
-
Associate Director, Clinical Regulatory Writing
1 month ago
Mississauga, Ontario, C4W, Peel region, Canada AstraZeneca Full timeKey Responsibilities:The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically meaningful clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core therapeutic areas in all...
-
Mississauga, Ontario, C4W, Peel region, Canada AstraZeneca Full timeBioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca therapies, while supporting our internal stakeholders with medical insight and expertise. BPM aims to lead AstraZeneca in achieving scientific leadership, being a great place to...
-
Medical Director
3 weeks ago
Brampton, Ontario, C6S, Peel region, Canada MENTUS RECRUITMENT LTD Full timeMedical Director and Consultant Psychiatrist Job Opportunity Mentusrecruitment are working in partnership with a leading independent healthcare provider to recruit for the Medical Director and Consultant Psychiatrist at their premier hospital in Lincolnshire. About the Hospital: The private hospital offers first class patient care and has a therapeutic...
-
Assistant Center Director
4 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada DIABSOLUT INC. Full timeOur Client, leaders in the field of eyecare, are seeking an Assistant Center Director. The Assistant Center Director will report directly to the Center Director and lead the team to ensure that operational goals are met. With innovation, the individual will assist the Center Director with all duties and measures involved.ResponsibilitiesManaging clinic...
-
National IT Director
4 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada Kuehne + Nagel AS Full timeJoin Us as National IT Director at Kuehne+Nagel CanadaAre you ready for an exciting IT leadership opportunity with the global leader in logistics? At Kuehne+Nagel, we are looking for a dynamic National IT Director to join our Canadian head office in Toronto and lead our IT strategy and operations.Your Role• Lead the development, implementation, and...
-
Director, Business Development
1 month ago
Mississauga, Ontario, C4W, Peel region, Canada Bayshore Healthcare Full timeJob Description JOB SUMMARY Reporting to the Divisional Director of Business Development, this position will be responsible for leading and facilitating the growth of Bayshore Healthcare's Specialty Rx Division across Canada. The primary focus will involve establishing and nurturing robust partnerships with pharmaceutical companies in Canada to cultivate...
-
Mississauga, Ontario, C4W, Peel region, Canada AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...
-
Senior Director, Patient Safety Physician V&I
3 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada AstraZeneca Full timeJoin our Patient Safety team! Job Title: Senior Director, Patient Safety Physician, V&I Location: Onsite 3 days in Gaithersburg MD OR Mississauga CAN OR Barcelona SPAIN ABOUT ASTRAZENECA At AstraZeneca, our values-based culture contributes to a desirable working environment, a purposeful mission of putting patients first who benefit from following...
-
National IT Director Tor ZI
4 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada Kuehne + Nagel AS Full timeJoin Us as National IT Director at Kuehne+Nagel CanadaAre you ready for an exciting IT leadership opportunity with the global leader in logistics? At Kuehne+Nagel, we are looking for a dynamic National IT Director to join our Canadian head office in Toronto and lead our IT strategy and operations.Your RoleLead the development, implementation, and maintenance...
-
Director, Sales Unitron Canada
4 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada Sonova Group Full timeYou enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable...
-
Director, Healthcare Analytics
1 month ago
Mississauga, Ontario, C4W, Peel region, Canada AstraZeneca Full timeJob title: Director, Healthcare Analytics Location: Mississauga (Canada) At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of...
-
Sr Director Market Access
1 month ago
Mississauga, Ontario, C4W, Peel region, Canada The Goddard School of Concord , NC Full timeWhen we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the...
-
Project Director
1 month ago
Mississauga, Ontario, C4W, Peel region, Canada CO 30 TC1 Bird Industrial Management Services Ltd. Full timeProject Director Where Greatness Grows The greatest achievements in history are borne from the greatness within people – where human potential meets vision, and passion fuels evolution. Unlocking this potential is the most important thing we do at Bird. As a leader in Canadian construction for over 100 years, the impact of our team is etched deeply within...
-
Director of Customer Success
4 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada BoomerangFX Full timeWhy BoomerangFX?BoomerangFX was recently recognized by the Deloitte Fast 500 program as the 5th fastest growing technology company in Canada and the 50th fastest growing company in North America. We specialize in offering healthcare SaaS solutions offering integrated clinic practice management software, digital marketing and e-learning solutions to the...
-
Director Of Finance
4 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada Viva Recruiters Full timeIn this pivotal role, you'll spearhead our financial operations, focusing on comprehensive financial reporting, budgeting, and strategic planning across all business areas. Your expertise will be crucial in driving the organization towards achieving its short and long-term goals.Responsibilities:Lead the financial reporting process, including the...
-
Clinic Manager
4 months ago
Mississauga, Ontario, Peel region, Canada Skin Vitality Medical Clinic Full timeSkin Vitality Medical Clinic is the #1 Provider of Botox®, Juvéderm®, CoolSculpting®, PRP Hair Restoration, Sculptra®, EMSculpt® and Fraxel® in Canada with 13 Locations in Ontario. We have grown 1000% in the last two years, opening 4 new locations this year. If it’s growth within a company you are looking for, look no further.We are seeking an...
-
Engineering Director, Nuclear
1 month ago
Mississauga, Ontario, C4W, Peel region, Canada Bird Construction Full timeEngineering Director, Nuclear page is loaded Engineering Director, Nuclear Apply locations Mississauga, ON time type Full time posted on Posted 30+ Days Ago job requisition id JR-6103 Engineering Manager, Nuclear Where Greatness Grows The greatest achievements in history are borne from the greatness within people – where human potential meets vision, and...
-
Finance Director
1 month ago
Mississauga, Ontario, C4W, Peel region, Canada Trexo Robotics Inc. Full timeAbout UsTrexo Robotics (Y Combinator Company) is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. The device is currently being used by hundreds of families and the best hospitals across...
-
Associate Director, External Communications
3 weeks ago
Mississauga, Ontario, C4W, Peel region, Canada AstraZeneca GmbH Full timeWorking in a dynamic team within AstraZeneca’s Vaccines & Immune therapies unit, this role will work with Senior Directors to build communications programs to coordinate and orchestrate news flow on behalf of our portfolio and pipeline, raising awareness of our efforts to bring transformative vaccines and antibodies to protect against viral and bacterial...