Medical Writer, Scientific & Medical Writing, Clinical Pharmacology
Newark Metro Area, NJ
1. Support development of clinical submission documents (preparation and management of clinical pharmacology sections of regulatory submissions, eg, CTD summary documents [Module 2.7], Clinical Overview [Module 2.5], and individual study reports [Module 5]).
2. Respond to Health Authority questions as needed (eg, prepare response documents).
3. Facilitate key message and document review meetings and discussions.
4. Provide medical writing support for Clinical Pharmacology studies, including Phase 1/2a clinical study reports and stand-alone pharmacokinetic (PK) reports.
5. Participate in study and clinical team meetings and assist the teams in resolving issues related to document preparation as needed.
6. Gather and review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation and prepare such data outputs.
7. Participate in the preparation of possible abstracts and/or journal submissions.
8. Any other related tasks as may be required, review and/or preparation of documents such as drop-in sections to the Investigator s Brochure or DSURs/PSURs.
Knowledge of FDA, EMA, and ICH guidelines preferred
Understanding of the drug development process
Extensive experience with writing all types of clinical & regulatory documents and with registration dossiers for worldwide use, including experience with summarizing scientific or clinical data
Experience working with CROs
Expertise in multiple therapeutic areas and phases of clinical development, especially Clinical Pharmacology
Ability to work with complex projects and within cross-functional teams
Excellent grammatical and communication skills, both written and oral
Expertise in MS WORD, including the ability to solve technical problems with WORD templates