Are you energized by a medical writing role that allows you to leverage your scientific knowledge while driving compliance in support of the business? If so, the Senior Medical Writer role could be an ideal opportunity to explore!
GSK is seeking a motivated Senior Scientific Writer who is passionate about science and eager to contribute to vaccine development at a global organization. This important role is an opportunity to ensure the preparation of quality documents in support of one or more exciting vaccine development programs.
This position is based at our US Research and Development Center (RDC) in Rockville, Maryland, but remote working may be possible for those in other geographic locations within time zones that can continue to support our global teams with flexibility. Experience developing documents necessary for this position include clinical concept protocols/protocols, informed consents, clinical study reports, investigator brochures and documents supporting submission to regulatory authorities.
The ideal candidate will:
- Possess strong verbal and written communication skills with at least 3 years of medical writing experience;
- Demonstrate a thorough understanding of clinical trials; and
- Be flexible working efficiently in a matrix environment across time zones (e.g., with colleagues based in the United States, Europe, and India),
As an individual responsible for Medical Writing deliverables, the Senior Medical Writer is expected to work on assignments independently, facilitating delivery of quality written documents that adhere to the standards of the global organization through proactive coordination of stakeholders to build content. The Senior Medical Writer is accountable for the final deliverable and is expected to work in matrix environment.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Why you?Basic Qualifications:
- Contribute to documents and activities to be included in registration files.
- Author clinical documents supporting vaccine studies following defined templates.
- Ensure the consistency and quality level of all documents that are issued.
- Actively participate in all aspects of document development planning, coordination and review meetings to integrate and address stakeholder comments.
- Manage a minimum of 2-3 assignments simultaneously.
- Proactively raise and discuss concerns/ issues in an open and timely manner and within the global team at GSK Vaccines to promote high scientific standards by pointing out any potential inconsistencies or inaccuracies and proposing alternative wording or strategies.
- Have familiarity with navigating electronic Trial Master Files (eTMFs), i.e., Veeva Vault.
We are looking for professionals with these required skills to achieve our goals:
- Master's Degree in life sciences or medical background.
- Experience with International Committee for Harmonization (ICH) / Good Clinical Practice (GCP).
- Expertise in statistical principles used in clinical research.
- Expertise in MS Word & Excel and PowerPoint .
If you have the following characteristics, it would be a plus:
- Doctor of Medicine degree (MD)
- PhD , Doctor of Medicine degree (MD) or PharmD
- Possesses a good understanding of basic immunology and area of assigned vaccine project.
- Demonstrates knowledge of scientific methodology in the design, conduct and description of clinical research.
- Demonstrates understanding of how to analyze and describe clinical results.
- Understands the organization of clinical study reports and scientific presentations.
are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity
along with Courage, Accountability, Development
, and Teamwork
. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust,
the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record