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Summary:
ln this vital role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities.
Responsibilities:
Author or oversee the authoring of all regulatory submission documents including Clinical
Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol
Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda,
eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric
Investigation Plans
Conduct the formal review and approval of authored documents, following applicable
standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions,
including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence
Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as
assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines
Preferred Qualifications:
Experience leading writing activities for new or supplemental drug applications/biologics
license applications is strongly preferred
Experience with regulatory documents in Regulatory Affairs, Research, Development or
related area
5+years of experience in medical writing in the Biotech/Pharmaceutical industry
Top 3 Must Have Skill Sets:
Experience leading writing activities for new or supplemental drug applications/biologics
license applications is strongly preferred
Experience with regulatory documents in Regulatory Affairs, Research, Development or
related area
5+years of experience in medical writing in the Biotech/Pharmaceutical industry
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Date Posted: 03 May 2024
Job Expired - Click here to search for similar jobs