Principal Medical Writing Consultant
For the past 20 years, Pro
Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), Pro
Pharma partners with its clients through an
-
- operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro
Pharma offers an
-
- end suite of fully customizable consulting solutions that
- risk and accelerate our partners’ most
- profile drug and device programs.
The Principal Medical Writer position is responsible for authoring medical writing deliverables with a focus on quality, accuracy, and efficiency, and provides medical writing support to Pro
Pharma clients.
The role will be offered on a contract basis and require approximately a 20 hour commitment per week. There is potential opportunity for this role to progress to full time hours over time. We are looking for candidates based in the UK or EU but the role can be offered on a remote basis.
Ideally candidates will have early phase experience within either Neurology or Oncology.
Essential Functions:
- and
- related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable.
CTD
- level documents) as assigned.
- functional coordination of resources (e. g. , internal resources/consultants) to manage medical writing and QC deliverables as assigned.
- quality medical writing deliverables (i. e. , clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e. g. , PBRER, IND, NDA, BLA, MAA, e
CTD submission level documents).
- approved templates.
- text tables against statistical output).
- related administrative tasks (e. g. , creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
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- scope tasks to medical writing leadership.
Necessary Skills & Abilities
- management skills and contacts management team proactively when additional support and resources are needed.
Educational and Experience Requirements
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***Pro
Pharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
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