Senior Medical Writer
3 tygodni temu
Senior Medical Writer
The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The senior medical writer understands clinical trials design and interpretation of statistically analysed clinical research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The Senior Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.
Key Responsibilities include, but are not limited to:
- Completes assignments independently or for more complex documents, under guidance of a mentor.
- Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
- Ensures high integrity of data interpretation, following negotiation with document team.
- Ensures the consistency and quality level of all documents that are issued.
- Actively participates in all planning, coordination and review meetings.
- Ability to work on 2-3 assignments simultaneously.
- Proactively raises and discusses concerns/issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
- Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers).
- Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.
Requirements:
- PhD or equivalent expertise (e.g., a master's degree with a minimum of 2 years' relevant experience).
- Up to 5 years clinical regulatory writing experience in the pharmaceutical industry.
- A good understanding of basic drug development.
- Knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
- Understanding of how to interpret, describe and document clinical data.
- Working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
- Strong IT skills.
- Excellent English language skills (verbal and written).
Why GSK?
- Career at one of the leading global healthcare companies.
- Contract of employment.
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
- Hybrid working model (where GSK site are in Poland).
- Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working from the office, short Fridays option, health & well-being activities).
- Life insurance and pension plan.
- Private medical package with additional preventive healthcare services for employees and their eligible dependents.
- Sports cards (Multisport).
- Possibilities of development within the role and company's structure.
- Personalized learning approach (internal trainings, mentoring, access to online training platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
- Supportive community and integration events.
- Modern office with creative rooms, fresh fruits every day.
Inclusion at GSK:
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
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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/Affirmative Action Employer. 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.
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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
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