Sr. Medical Writing Manager, Regulatory (Onsite or Remote)

Location
United States
Posted
Aug 29, 2020
Ref
581880263
Required Education
Bachelors Degree
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference. If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.

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.**