Medical Writing Asset Lead-Oncology

4 weeks ago

Mississauga, Canada GlaxoSmithKline Full time
Site Name: Mississauga Milverton Drive, Greater Poland
Posted Date: Aug 19 2024

Job Description

Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so this Medical Writing Asset Lead role could be an ideal opportunity to consider.

As a Medical Writing Asset Lead, you will lead therapy area specific medical writing projects or programs as appropriate in support of the clinical strategy to meet business and regulatory needs, and potentially leading projects across products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Provides key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents including, but not limited to, protocols, clinical study reports, clinical study register summaries, common technical document summaries and Clinical Overview, briefing documents for regulatory authorities, responses to regulatory authority questions, clinical sections of the IMPD for clinical trial applications, investigator brochures and annual reports.

Leads matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed. Ensures global approach for submissions as appropriate, including the use of core global modules, supplemented by local modules as necessary. Ideally works in collaboration with GRA to ensure business needs are met for new chemical entities and post approval documentation.

Plans and successfully implements large submissions independently or in conjunction with the Medical Writing Director, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary. Recommends solutions for problems that affect timelines. Provides guidance and facilitation to submission teams in development of detailed submission plan.

Ideally demonstrates an understanding of the interdependences of various contributing functions and manages problems affecting timelines as necessary. Ideally demonstrates an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.

Proposes resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.

Effectively organizes content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions. Acts as lead author on submissions.

Actively contributes to development of training materials for therapeutic area scientists and provides mentoring and/or training on clinical documentation and submission planning to individuals or teams. Ideally, proactively identifies medical writing training needs for staff and develops/implements training sessions.

Has ability to priorities effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s Degree

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • PhD, PharmD, MPH, MS or other post-graduate degree
  • Possesses highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at senior level.
  • Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
  • Experience analyzing complex scientific & operational information and implementing effective solutions.

#LI-GSK

#LI-HYBRID

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an equal opportunity employer committed to diversity and inclusion.We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

#J-18808-Ljbffr

  • Medical Writing Asset Lead-oncology

    1 month ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive, Greater Poland **Posted Date**: Aug 19 2024 - Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so this Medical Writing Asset Lead role could be an ideal opportunity to consider. _ - As a Medical Writing Asset Lead, you will lead therapy area specific...

  • Medical Writing Asset Lead-Oncology

    3 weeks ago

    Mississauga, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton Drive, Greater PolandPosted Date: Aug 19 2024Job DescriptionAre you looking for a highly visible medical writing role that broadens your project management capabilities? If so this Medical Writing Asset Lead role could be an ideal opportunity to consider. As a Medical Writing Asset Lead, you will lead therapy area specific...

  • Medical Advisor, Oncology

    4 months ago

    Mississauga, Canada Ipsen Biopharmaceuticals Canada Inc. Full time

    **Summary** As the Medical Advisor, Oncology, you will be responsible for the development of the annual national medical affairs strategy and implementation within the Oncology therapeutic area. This includes coordinating an annual medical strategic planning exercise with MSLs for synchronized development of the National Medical Plan with the MSL territory...

  • Medical Science Liaison- Oncology

    3 months ago

    Mississauga, Canada Merck KGaA Darmstadt Germany Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Director, Medical Writing

    3 weeks ago

    Mississauga, Canada Maryland Medical Day Services Llc Full time

    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...

  • Director, Medical Writing

    4 weeks ago

    Mississauga, Canada Maryland Medical Day Services Llc Full time

    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...

  • Director, Medical Writing

    3 weeks ago

    Mississauga, Canada Maryland Medical Day Services Llc Full time

    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...

  • Director, Medical Writing

    4 weeks ago

    Mississauga, Canada Maryland Medical Day Services Llc Full time

    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...

  • Director, Medical Writing

    4 weeks ago

    Mississauga, Ontario, C4W, Peel region, Canada Maryland Medical Day Services Llc Full time

    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...

  • Oncology Medical Training Leader

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    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 individualized flexibility, our ways of working allow employees to balance personal...

  • Product Manager, Oncology

    3 months ago

    Mississauga, Canada Ipsen Biopharmaceuticals Canada Inc. Full time

    Genericization, New Product launch and Growth Molecules. If these terms captured your attention, then I have the perfect Product Manager role for you. As our Oncology Product Manager, you will develop strategies and tactics for oncology products. Specific areas of focus include brand plan development and implementation, target customer identification and...

  • Medical Evidence Lead

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    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 individualized flexibility, our ways of working allow employees to balance personal...

  • Business Specialist Oncology Medical Affairs

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    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 individualized flexibility, our ways of working allow employees to balance personal...

  • Writing Intern

    3 months ago

    Mississauga, Canada Baylis Medical Technologies Inc. Full time

    **Title**: Writing Intern **Job Type**: Contract **Duration**: 6 months **A peek into purpose** **Role commitments** - **Historical Research**: Conduct thorough research to gather detailed information on the company's history, including significant milestones, changes, and achievements. This will involve reviewing archival materials, previous...

  • Director Medical Writing Submission Facilitator

    3 weeks ago

    Mississauga, Canada GlaxoSmithKline Full time

    strong>Site Name: Wavre, Italy - Siena, MississaugaPosted Date: Aug 30 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as...

  • Head of Centre for Oncology Data Excellence

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    Join us in our ambitious journey to eliminate cancer as a cause of death. As the Head of Centre for Oncology Data Excellence, you will lead a team focused on delivering best-in-class scientifically rigorous research to support the Evidence Generation organization. You will be part of the fastest growing team within AstraZeneca and across the industry, with...

  • Oncology Operations Coordinator, Business Planning

    1 week ago

    Mississauga, Canada AstraZeneca Full time

    **_*This is a 12-month contract*_** 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 individualized flexibility, our ways of working...

  • Oncology Pharmacy Technician

    4 weeks ago

    Mississauga, Ontario, Canada Trillium Health Partners Full time

    Job Overview Position: Oncology Pharmacy Technician Department: Pharmacy Services Role Level: Allied Health Professional (Salary Range: $31.37 to $36.16) Employment Status: Full-Time Work Locations: Various sites within the healthcare network Work Schedule: Monday to Friday, with potential weekend shifts Organization Overview: ...

  • Director Medical Writing Submission Facilitator

    3 weeks ago

    Mississauga, Canada GlaxoSmithKline Full time

    Site Name: Wavre, Italy - Siena, MississaugaPosted Date: Aug 30 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and...

  • Director Medical Writing Submission Facilitator

    3 weeks ago

    Mississauga, Canada GlaxoSmithKline Full time

    Site Name: Wavre, Italy - Siena, MississaugaPosted Date: Aug 30 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and...