Sr. Medical Writer - Briefing Documents for FDA - REMOTE
Proclinical is currently recruiting for a remotely based Senior Medical Writer for a consulting firm located in Cambridge, MA. As the Senior Medical Writer, you will report to designated project leads for billable activities and will collaborate with the Company Executive Team for non-billable activities.
- Responsible for the creation, content development, formatting, editing, review and/or updates to of any document that supports regulatory interactions or meetings (e.g., briefing documents for meetings with regulatory agencies, briefing document for CHMP Oral Explanation or SAG, briefing books for drug/biologic advisory committee meetings, panel packs for device advisory committee meetings, clinical protocols, applications for approval).
- Collaborate with the client to create a document that aligns with the agreed upon messages and supporting facts, data and examples that credibly represent the available data and to establish target dates for draft iterations and final version in line with the agreed upon contracted services.
- Each generated or updated version will be supplied in a timely manner to the client for final editing and quality control, such that the client is accountable for final content and accuracy.
- Perform both Billable and Non-Billable Activities.
- Perform agreed upon services for the company's third-party clients in collaboration with other company personnel on designated billable activities as set-out in executed service contracts.
Skills and Requirements:
- A degree (bachelor's or above) in communications, science, or related field.
- At least three (3) years' experience medical/scientific writing in a pharmaceutical or regulatory environment.
- Familiarity with Microsoft Office programs, including MS Word, Excel, and PowerPoint.
- Familiarity with Salesforce, Dropbox, Citrix preferred.
- Excellent people skills, with an ability to partner with a dynamic leadership team.
- Excellent written and verbal communication skills.
- Possess personal qualities of integrity, credibility, and commitment to corporate mission.
- Flexible and able to multitask; can work within an ambiguous, fast-moving environment, while also driving toward clarity and solutions; demonstrated resourcefulness in setting priorities and guiding investment in people and systems.
If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-223-4835 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.