Job Description Summary:
The Associate Director, Scientific Writing directs and provides technical and operational support to the activities of the medical writing staff and associated projects. This includes, but is not limited to: directing, authoring, editing and providing input to clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. He/she may also author/edit and/or direct the development of pre-clinical documents.
The Associate Director, Scientific Writing will collaborate on the development of clinical documents in accordance with all applicable regulations including, but not limited to. Good Clinical Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association [EMA] Clinical Trials Directives, International Congress on Harmonisation [ICH] guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.
The incumbent works cross-functionally with internal departments and external resources on Medical Writing related issues.Job Description:
- In adherence with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines) company SOPs and internal style guides, researches, authors, and edits:
- Works with the clinical and regulatory teams to prepare clinical documents, including, but not limited to, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, Clinical Summaries of Safety and Efficacy, Clinical Overview, and pre-clinical study protocols and reports under strict timelines.
- Provides leadership in planning and completing key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorisation Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports).
- Ensures key messages are clear and consistent within and across documents.
- Contributes strategically and scientifically at the project and/or study team level.
- Provides editorial or review support for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals.
- Collaborates with cross-functional team members (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, Quality, CMC, etc.) to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents.
- Ensures a consistent style of document presentation to maintain quality and ease of review and adherence to company standards.
- Procures and manages external medical writing resources (e.g., Contract Research Organizations [CRO], document quality reviewers, freelance medical writers, etc.).
- Contributes to the development and standardization of templates and related processes. Manages, coaches and mentors direct reports.
- Assists in the daytoday operational activities and other assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
- Advanced degree (PhD or PharmD) with a minimum of 5 years of medical writing experience in a pharmaceutical company or related environment OR a Bachelor's degree in a scientific discipline with 10+ years of experience in a pharmaceutical, biotechnology, or CRO.
* Special knowledge or skills needed and/or licenses or certificates required.
- At least 5 years of experience in a medical writing role, including participation in submissions to the US FDA (NDA, BLA) and/or EMA (MAA).
- Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections.
- Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data.
- Demonstrated ability to incorporate pre-clinical data into clinical and regulatory documents.
- Excellent understanding of biostatistics reporting standards and awareness of the associated biostatistics concepts.
- Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure.
- Ability to influence without direct authority.
- Proficiency with Microsoft Office and use of electronic document templates.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects and to complete high-quality documents according to tight timelines.
*Special knowledge or skills and/or licenses or certificates preferred.
- Ability to assist with other regulatory or clinical tasks.
- Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents.
- Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools.
- Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates.
- Demonstrated people and project management experience.
* Travel requirements