Sepracor
-
Marlborough,
MA
The Director/Senior Director, Medical Writing, will be responsible for managing and
coordinating all medical writing activities for Sepracor Inc. Research and
Development including protocols, clinical study reports, Investigator brochures, IND
and NDA annual reports and any other document involved in a regulatory submission. The Director/Senior Director will be responsible for line management of all staff within the Medical Writing function.
Essential Functions 1. Oversee generation of the clinical portion of all IND filings.
2. Oversee production of Integrated Clinical Study Reports, Integrated summaries of Safety and Efficacy, Annual IND reports, IND safety reports to support NDAs.
3. Maintain and develop protocol and clinical reporting templates and any other SOPs associated with the medical writing function.
4. Oversee Investigator Brochure templates and ensure Investigator brochures are produced in accordance with regulatory and Sepracor inc policies.
5. Manage consistency of style format and content for all documents required for international regulatory submissions.
6. Serve as primary liaison between all departments in Research and Development for the production of regulatory documents.
7. Mentor and manage all medical writing staff. Develop functional structure and job descriptions to allow growth and development opportunities for Medical writing staff
8. Ensure that all documents produced by the Medical Writing Department have undergone appropriate Quality control and consistency checks to meet internal standards as set by Sepracor Inc.
Minimum education requirements Bachelors
Experience required 5 - 7 Years
Knowledge & skills (general and technical) The position requires an individual with excellent organizational skills.
The individual must:
~ possess excellent written and oral communication skills.
~ be highly self-motivated.
~ be a strong team player and provide a vision to develop the medical writing group.
~ demonstrate the ability to manage, mentor and train individuals.
~ possess a fundamental working knowledge of ICH, FDA and EMEA GCP’s.
Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters while working at Sepracor is considered confidential.
Compliance Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sepracor are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Marlborough, MA
Marlborough, Massachusetts
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