Senior Manager Regulatory Writing
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Location
REMOTE
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Sector:
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Job type:
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Contact:
Fahd Joudi
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Contact email:
f.joudi@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
about 1 month ago
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Expiry date:
2023-05-12
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Startdate:
ASAP
Principal/Senior Manager Medical Writing
Your responsibilities include, but are not limited to:
Overall, the Senior Medical Writer is responsible for writing, reviewing, and overseeing the production of clinical, nonclinical, and regultaory documents to support product development and marketing applications.
- Authoring and managing document review and finalization process
- Managing timelines for Medical Writing documents you are authoring
- Reviewing and editing documents written by other functional teams
- Participating in clinical study team meetings and other appropriate clinical development teams meetings as needed to provide input regarding MW deliverables, timelines, and process
- Coordinate with subject matter experts (SMEs) and key stakeholders regarding appropriate document content
- Document authoring includes, but is not limited to: clinical study protocols and amendments, clinical study reports, Investigator’s Brochures, Development Safety Update Reports and other annual reports (eg, ODD annual reports), and CTD sections for IND/NDA submissions and may include authoring of other regulatory documents (eg, briefing documents, responses to information requests)
- Document editing and reviewing may include: nonclinical and/or clinical pharmacology reports and/or CTD sections, CMC documents (as needed), and other documents as needed
- Adhere to company Style Guide, templates, and SOPs for document development
- Participate in the development of departmental SOPs and cross-functional process development in a gowing company
Your profile:
- Fluent in English
- Excellent and established medical writing skills (at least 5 years experience as a medical writer in industry)
- Ability to write clean and concise documents
- Ability to understand and interpret clinical and scientific data
- Ability to author documents in a manner that is understandable to a variety of audiences
- Knowledge of current regulatory guidelines including but not limited to ICH guidelines
- Proficient in MS Word, Power Point, and Outlook
- Excellent time management skills and the ability to manage multiple ongoing projects simultaneously
- Ability to build partnerships with key stakeholders from other functions to ensure strategic business goals are met
Our offer:
- Competitive compensation
- An exciting and multifaceted full-time position
- Become part of a passionate, creative, and collaborative international team
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