Director of Medical Writing

Constellation Pharmaceuticals is a clinical-stage biopharmaceutical company using expertise in epigenetics to discover and develop novel therapeutics that address serious needs in patients with cancers associated with abnormal gene expression.
Director of Medical Writing

We are looking to add a Director of Medical Writing to our team. The primary deliverables for this role are clinical regulatory documents according to applicable regulations. It is envisioned that this person will play a leadership role in future key regulatory submissions to the FDA and EMA.

 
How you will spend your day:

• Provide leadership in planning and completing key submission documents (e.g., Clinical Summaries of Safety and Efficacy, Clinical Overview) for submissions to the FDA and EMA
• Contribute to overall project management and to cross-functional working groups (clinical operations, clinical development, data management, statistics) as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
• Manage the work of CRO contract writers, as needed
• Work with the clinical and regulatory teams to prepare protocols, clinical study reports, Investigator’s brochures, safety updates, and IND clinical sections in CTD format under strict timelines
• Participate in recruiting and mentoring of staff, and budget planning

 
Key Things about you:

• BS required, advanced degree in scientific discipline preferred
• At least 5 years in medical writing focused in oncology, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA), with supervisory experience
• Experienced 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, with an aptitude for compilation, analysis, and presentation of data
• Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines
• Wide knowledge of development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
• Independently motivated, and good problem-solving ability
• Ability to think strategically to further project and departmental development

 

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Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.

We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.