Offer summary

Qualifications:

Minimum of 3 years of experience in writing clinical and regulatory documents for drugs, biologics, and medical devices., Strong knowledge of clinical research principles and the ability to interpret complex data., Familiarity with global regulatory bodies and submission requirements., Experience in writing and editing scientific documents is preferred..

Key responsabilities:

Author high-quality regulatory writing deliverables including protocols, study reports, and patient narratives.

Adhere to established regulatory standards and guidelines while completing writing deliverables on time.

Interact with clients and manage deliverable timelines, leading team meetings as necessary.

Coordinate QC reviews of documents and assist with project-related administrative tasks.

Job description

For the past 20 years, ProPharma 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), ProPharma partners with its clients through an advise-build-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, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma are looking for an experienced Medical Writer to join the team to support the our global growth; this is a fully remote role across any of the ProPharma entities. The Medical Writer position is responsible for authoring regulatory writing deliverables that focus on quality, accuracy, and efficiency and for providing regulatory writing support to ProPharma clients.

Essential Functions:

Author (write / edit) high-quality regulatory writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) including but not limited to protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs / CERs, DSURs, and plain language summaries. May participate in authoring more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents) under the supervision of senior personnel.
Adhere to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2), EU MDR / IVDR, Company standard operating procedures, client standards, and Company- and / or client-approved templates.
Strive to complete writing deliverables on time and within budget.
Interact and communicate directly with clients, lead team meetings (e.g., project kickoff, comment review), and manage the deliverable timelines, with support from senior personnel (as needed).
Interact and collaborate as needed with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
Coordinate QC reviews of documents and maintain audit trails of changes as applicable.
Review statistical analysis plans and table / figure / listing shells (as applicable) for appropriate content, grammar, format, and consistency.
If requested by supervisor, perform QC review (e.g., reviews in-text tables against statistical output).
Assist with project-related administrative tasks (e.g., creating and maintaining timelines, updating deliverable trackers, and hosting internal / client meetings) with support from senior personnel (as needed).
Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to regulatory writing.
Understand budget specifications for assigned deliverables, work within the budgeted hours, and communicate out-of-scope tasks to regulatory writing leadership.

Ideal skills and requirements:

Knowledge of clinical research principles and the ability to interpret and present clinical data and other complex information.
Understanding of global regulatory bodies and applicable regulations and guidelines.
Understanding of regulatory submission requirements and processes. ·
Minimum of 3 years of experience writing clinical and regulatory documents for drugs, biologics, medical devices/diagnostics for a CRO, pharmaceutical company, or biotechnology company. ·
Experience writing & editing scientific documents or experience in reviewing scientific data preferred.

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.

***ProPharma 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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