Job Category: Pharmaceutical & Biotech

Assoc Dir, Medical Writing (DG)

Job Location: Parsippany, NJ (see all jobs in NJ)

Work Type: Remote

Date Posted: 2022-02-16

Associate Director, Medical Writing - REMOTE

Our client is looking for a highly motivated, independent and talented Associate Director, Medical Writing with a minimum of 10 years’ relevant medical or scientific writing experience in the Pharmaceutical Industry (oncology experience preferred, but not required if the candidate has demonstrated experience in other indication[s]). As Associate Director, Medical Writing, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the portfolio. As Associate Director, Medical Writing, you will be responsible for ensuring that scientifically robust messages and arguments are developed and conveyed consistency across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.

The successful candidate will have strong analytical skills, high quality standards and is committed to meet deadlines. In addition, it is essential that you are well-organized, proactive, and flexible, and have the ability to work on multiple complex tasks simultaneously.

We offer a position where you will be involved in strategic project, as well as trial-related activities, and will have ample opportunities, responsibilities, and influence on defining your own work. You will also be involved in leading the development of processes and tools to support further development of the department.

KEY ACCOUNTABILITIES:
Independently draft and edit documents used to support clinical trial conduct and reporting, including clinical trial protocols, investigator’s brochures, and clinical study reports. Additionally, you will lead the drafting and editing of Health Authority briefing packages, Health Authority responses, and CTD submission documents. Drive trial team participation in the preparation of such documents, including calling/scheduling/facilitating meetings, developing and managing timelines, document review, and decisions. Provide peer review and editing support for other clinical
egulatory documents, as needed. Adhere to guidelines, SOPs, and practices and technical and industry standards during all aspects of work. Proactively support developing and reviewing standard processes and templates. Work effectively and lead in cross-functional working groups.

SKILLS & EXPERIENCE:
At least 10 years’ experience as a clinical or regulatory medical writer in the pharmaceutical industry, preferably within oncology. Less than 10 years medical writing experience may be considered, if the candidate has a demonstrated track record for writing or leading the writing of clinical documents in major regulatory filings (NDA, BLA, MAA). Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA). Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, EndNote, document management systems. Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical studies, and clinical study data collection and results reporting. Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates. Experience writing, at a minimum, protocols (Phase 1-3), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Paediatric Investigational Plans (PIPs) is preferred. Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports). Ability to interpret and summarize complex tabular and graphical data presentations.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

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