Search jobs > Mississauga, ON > Operation manager

Senior Manager, Medical Writing Operations

Alexion Pharmaceuticals
Canada,Mississauga
Full-time

To support Alexion’s mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team drives the development of strategic and compliant documents to enable clinical research and regulatory approval of new therapies, and ensures Alexion’s continued compliance with laws, policies, regulations, and public commitments for visibility and disclosure.

The Alexion Medical Writing (MW) team provides expert leadership and strategic authoring of high-quality clinical, nonclinical regulatory documents.

Alexion MW&CTT supports the Company’s core therapeutic areas in all phases of clinical development.

Accountabilities :

Support and facilitate operational processes across MW, including management support of vendors; recommendation, implementation, and maintenance of technology;

and contribute industry experience to support innovation projects across MW.

  • Support MW deliverable tracking, including confirmation of up-to-date document attributes and timing, budgets, and resourcing.
  • Support strategies to augment the internal team with vendor support and contribute to vendor oversight and project metrics to ensure vendor projects perform with maximum efficiency within established timelines, budgets, and quality standards.
  • Support maintenance of up-to-date knowledge of the latest technological document development / management tools to develop strategies to better support MW process improvement and troubleshoot / escalating technology-related issues within MW.
  • Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
  • Have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.
  • Ensure strategic organization, clarity, accuracy, format, and consistency of scientific content.
  • Proactively collaborate with other functions, including, as needed, with external service providers / contractors.
  • Develop effective collaborations with other functional lines within Alexion, and keep abreast of regulatory, industry, and medical writing knowledge and best practice.
  • Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Alexion MW.

Essential Skills / Experience :

  • Life Sciences degree or equivalent
  • Experience in regulatory documentation and / or medical communications
  • Medical writing Operations experience in the pharmaceutical industry
  • Knowledge of the technical and regulatory requirements related to the role

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 we need 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.

Explore rare opportunities at Alexion. Rare disease biopharma is at the forefront of biomedical science. Remaining transparent, objective and ethical, we push the boundaries of science, translating complex biology into transformative medicines.

Uniquely positioned with resources and global reach we also have potent capabilities that are shaping the future of Rare disease into new areas of great unmet need to help people fully live their best lives.

Ready to make a difference? Apply now!

LiHybrid

Date Posted

05-Nov-2024

Closing Date

08-Dec-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact .

Alexion participates in E-Verify.

1 day ago
Related jobs
Alexion Pharmaceuticals
Mississauga, Ontario

Medical writing Operations experience in the pharmaceutical industry. To support Alexion’s mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team drives the development of strategic and compliant documents to enable clinical ...

Pinchin
Mississauga, Ontario

Operations Manager/Senior Engineer . Pinchin’s Geotechnical Services Group is growing currently recruiting for an Operations Manager and Senior Geotechnical Engineer to assist with the growth of the Geotechnical Practice in the GTA. A Day in the life of Operation Manager/Senior Geotechnical Engineer...

Rewind Software
Toronto, Ontario

As a Senior  Revenue Operations Manager, you will report directly to the VP, Revenue. As a Senior Revenue Operations Manager, your focus will be to support the Revenue organization, specifically the Sales, Partnerships and Customer Support functions, while working cross-functionally with our Ma...

Co-operators
Toronto, Ontario

Working knowledge of operations, technical, and corporate insurance claims operations, regulatory audits, CEO/CFO certification reviews, privacy compliance, audit services, and external audit environments. The successful incumbent will be the senior operational control leader within Sovereign Nation...

IQVIA
Mississauga, Ontario

This home-based position will create scientific and medical communications deliverables with Lead Medical Writer quality, plus provide managerial leadership to a global medical writing team. Manager, Medical Communications Writing. IQVIA™ Medical Communications is seeking a partially billable Lead M...

First National
Toronto, Ontario

Senior Manager of Security Architecture and Operations in our Information Security department!. Ability to work effectively with business unit and IT department managers, including Application Development, Infrastructure, Operations, Network, Technical Support, and others. Maintain secure, resilient...

Procter & Gamble
Toronto, Ontario

Media Analytics and Operations Manager to join us full-time in Toronto as soon as possible. P&G Canada's Brand Operations Team is a strong multi-functional team comprised of expert media leaders focused on building industry leading media expertise, capabilities, and go to market strategies that driv...

BDO
Mississauga, Ontario

Senior Manager/Director, Operations Improvement Consulting. Operations Consulting team and own the following responsibilities:. Work closely with senior consultants and work collaboratively to execute deliverables. Support the growth of BDO’s Strategy and Operations Practice in the GTA within its ta...

Unilever
Toronto, Ontario

As Operations Manager, you will lead the production of our Rexdale Dressings portfolio. Operations Manager is the critical role for the site, and the incumbent must be prepared to lead members of the site community to success. Success is dependent on change, and the Operations Manager role is the Ch...

EY
Toronto, Ontario

As a Strategic Tax Operations Lead (Senior Manager or Manager Level), you will be part of our Tax Services team. Your role will focus on establishing relationships with clients at senior levels while working to consistently deliver exceptional client service across the tax processes. ...