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Skills: Clinical Regulatory Writing, Data Interpretation, ICH GCP Knowledge, Clinical Trial Design, Statistical Principles
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Poznan, Greater Poland Voivodeship, Poland · Remote OK
$150k–$224k/yr
Mid level$18B raised
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Job TitlePraktyki w sprzedaży sprzętu medycznego (all genders) Job Description Respiromix, Spółka z Grupy Philips, będąca liderem sprzedaży sprzętu medycznego w terapii oddechowej poszukuje kandydatów na praktyki do zesp…
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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who …
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Skills: Business Analysis, Systems Thinking, Stakeholder Management, Strategic Roadmapping, Root-Cause Analysis
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$167k–$278k/yr
Full-time
Annual Bonus, Share Based Long Term Incentive Program
Posted 35d ago
Apply by Jul 17
~40 hrs/week
Responsibilities
The Senior Medical Writer is responsible for authoring a range of clinical regulatory documents, including protocols and clinical study reports. They must coordinate with cross-functional stakeholders to ensure data integrity and quality standards are met for final deliverables.
Requirements
Candidates require up to 5 years of clinical regulatory writing experience in the pharmaceutical industry. Proficiency in ICH/GCP guidelines, scientific methodology, and statistical principles for clinical research is essential.
Full job description
Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D
Position Summary 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 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 Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.
This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
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.
Responsibilities
Up to 5 years clinical regulatory writing experience in the pharmaceutical industry
Possesses a good understanding of basic drug development
Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
Demonstrates understanding of how to interpret, describe and document clinical data.
Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
Possesses necessary computer skills and general computer literacy.
Excellent English language skills (verbal and written)
What we offer in the role You will join a team that values respectful collaboration, continuous learning and accountability. You will gain exposure to global teams and complex clinical programs. You will have clear opportunities to broaden your technical skills and take on increasing responsibility.
Skills
Polish Salary Range / Polski przedział wynagrodzenia: PLN 166,500 to PLN 277,500The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at [email protected] to discuss your needs.
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.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.
Related keywords
Medical WritingPharmaceutical IndustryClinical Study ReportsNDAMAACTD SubmissionInvestigator BrochuresBriefing DocumentsICHGCPDrug DevelopmentBiostatisticsRegulatory AffairsClinical TrialsR&D
We are uniting science, technology and talent to get ahead of disease together.
Our community guidelines: https://gsk.to/socialmedia
Offices: 79 New Oxford Street, London, England WC1A 1DG, GB · 5 Crescent Drive, Philadelphia, Pennsylvania PA 19112, US · Gunnels Wood Road, Stevenage, England SG1 2, GB · 9 Canton Rd, 23/F, Tower 6, The Gateway, Kowloon, Hong Kong ., HK · Bogota Corporate Center Av. Eldorado No. 69B – 45 / 9th Floor Bogotá, D.C., Bogota, Bogota, D.C. 110931, CO
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How many Healthcare jobs are open in Poznan, Poland right now?
There are currently 85 open healthcare positions in Poznan, Poland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Poznan, Poland?
Companies currently hiring include Roche, GSK, Haleon, bloom Hörakustik, Medtronic, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Poznan, Poland?
Yes — 65 of the 85 open healthcare positions offer remote or hybrid work (5 remote, 60 hybrid).
How do I apply for Healthcare jobs in Poznan, Poland?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.