Sr. Medical Writing Manager, Regulatory (Onsite or Remote)
- Employer
- MyoKardia, Inc (acquired by BMS)
- Location
- United States
- Start date
- Aug 29, 2020
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- Discipline
- Clinical, Medical Writing, Regulatory
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
SUMMARY:
The Senior Medical Writing Manager will be responsible for writing, reviewing, and preparing clinical and regulatory documents including protocols/amendments, investigator brochures, consent forms, regulatory briefings, DSURs, final study reports, sections of INDs, and NDAs. Reporting to the Head of Medical Writing, the Senior Medical Writing Manager will partner with Clinical, Regulatory, and other cross-functional teams in communicating critical information that supports product development, clinical data analysis, and document and report authoring.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Create high-quality documents that meet domestic and international regulatory submission standards.
- Drive document management from start to finish (ie, generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (eg, follow house style guide), and managing various processes (eg, reviews, QC, QA, formatting, and document archiving).
- Work with cross-functional groups to collaborate on document content and messaging, set priorities, and meet project timelines.
- Lead cross-functional initiatives related to document development.
- Coordinate and manage consulting writers as needed.
- Maintain medical writing processes, standards/SOPs, and systems/tools.
- Maintain document history and manage version control of documents.
EDUCATION/EXPERIENCE/SKILLS:
Education:
- BS, MS, or PhD, preferably in a scientific or medical field. Advanced degree preferred.
Experience:
- At least 5 - 7 years' experience in Medical Writing; biotechnology/pharmaceutical sector experience is required.
- Prior experience writing Clinical Study Reports.
- Prior experience crafting and compiling documents for inclusion in/support of milestone regulatory submissions (IND, NDA, MAA, etc.).
Knowledge/Skills/Abilities
- Excellent communication and writing skills, and the ability to collect, analyze, and present complex information in well-constructed and persuasive documents.
- Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines.
- Proficiency with medical terminology and ability to articulate drug development data, process, and regulatory submissions.
- Experience with Phase I-III clinical trials including international regulatory requirements.
- Skill with software applications, document templates, and document management systems.
- Ability to work closely with cross-functional teams and to drive deliverables to meet timelines in a fast-paced environment with shifting priorities.
**Though our preference is for an onsite candidate, we are open to a remote work arrangement with travel based on business needs.**
Company
MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science. MyoKardia is a clinical-stage bio pharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases. The company is pioneering a precision medicine approach to its discovery and development efforts by 1) understanding the bio mechanical underpinnings of disease; 2) targeting the proteins that modulate a given condition; 3) identifying patient populations with shared disease characteristics; and 4) applying learnings from research and clinical studies to inform and guide pipeline growth and product advancement. MyoKardia’s initial focus is on small molecule therapeutics aimed at the proteins of the heart that modulate cardiac muscle contraction to address diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224. Founded in September 2012 MyoKardia is headquartered in Brisbane, CA.
- Website
- http://www.myokardia.com/
- Phone
- 650-741-0900
- Location
-
1000 Sierra Point Parkway
Brisbane, CA 94005
US
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