Associate Director, Medical Writing

September 16

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Genmab

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1001 - 5000

💰 $134M Post-IPO Equity on 2010-06

Description

• Serve as an expert Medical Writer responsible for planning, developing, and writing clinical documents to support medical and regulatory activities across the Genmab portfolio. • Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages. • Lead, and actively contribute to, the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance as applicable. • Independently prepare (or oversee the work of others), edit, and finalize complex, strategic clinical and regulatory documents, including clinical trial protocols/amendments, investigator’s brochures, clinical study reports, PIPs, Health authority briefing packages, Health Authority responses, and clinical CTD submission documents.

Requirements

• BA/BS degree in life sciences and at least 10 years’ medical or scientific writing experience, in the pharmaceutical industry. • Oncology and immunology experience highly preferred. • Extensive experience writing protocols, investigator’s brochures, clinical study reports, Health Authority briefing packages, Health Authority responses, and Pediatric Investigational Plans (PIPs). • Experience authoring clinical components in regulatory filings (NDA, BLA, MAA). • Expert understanding and knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports), CTA/IND/HA regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting. • Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates. • Ability to interpret and summarize complex tabular and graphical data presentations. • Proficiency in the use and understanding of computer software (e.g., word processing, graphics, reference manager, EndNote, document management systems).