This site uses cookies. To find out more, see our Cookies Policy

Medical Writer, Clinical Affairs - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 2/16/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:
    2/16/2019

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Job Function Summary:

The Medical Writer, Clinical Affairs is responsible for the generation and development of documents relating to clinical evaluations and clinical investigations. This role is responsible for day to day execution of Clinical Evaluations. Within this role, the Medical Writer will lead a cross functional evaluation team to write and update Clinical Evaluation Plans, Reports and other associated documents. The medical writer is a pivotal role to ensure compliance with associated regulations and pivotal in ensuring that there is available evidence to support the safety and performance of the products designed, produced and manufactured by the company. The Medical Writer will perform and document systematic literature reviews, critically evaluate identified data and will interface with Regulatory, Quality Engineering, Product Management, Complaints, and medical professionals in order to achieve high-quality CERs as part of the product technical documentation.

The Medical Writer is also responsible for the development of study-related documents, including protocols, clinical investigational reports, investigator’s brochures, manuscripts and periodic reports. The Medical Writer will be an integral part of the tight-knit Clinical Affairs team and collaborate with Clinical Scientific Leads, Clinical Trial Managers and other key personnel. 

The Medical Writer is also responsible for optimizing processes for clinical evaluation and investigation as they relate to medical writing. This role requires great familiarity and application of the associated regulations and guidance, including MDR (2017/745), MDD, MEDDEV 2.7.1 Rev. 4 and other MEDDEV guidances, ISO 14155, 21 CFR 812.

This role will report to the Director, Clinical Affairs.

Job Functions:

  • Create and update Clinical Evaluation Plans, Reports in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR. Contribute to the Summary of Safety and Clinical Performance in alignment with EU MDR.
  • Perform comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required.
  • Serve as a subject matter expert on clinical aspects of Technical documentation.
  • Analyze available clinical evidence (data held by the manufacturer, published literature) to assist the Clinical Affairs team with clinical development strategy.
  • Write and or edit clinical study documentation, including clinical investigational plans/protocols, Investigator’s Brochures, Periodic reports, Clinical Investigational Reports/Clinical Study Reports. Ensure high quality study documentation that is submission-ready for various regulatory agency and external distribution.
  • Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals. Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission.
  • Write and/or contribute to abstracts and submissions of clinical data to various medical congresses or symposia. Work with medical professionals to ensure high quality submissions and data integrity.
  • Contribute to the development and optimization of Clinical Affairs SOPs.
  • Mentor and assist Clinical Affairs team members in the generation of effective visual and written communication.
Required Knowledge, Skills and Abilities
  • Strong interpersonal and communication skills.
  • Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives. 
  • Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions. 
  • Outstanding oral and written communication skills. 
  • Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review tools a plus.
  • Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidances, including 2.7/1 Revision 4 and 2.12/2 Revision 2, ISO 14155, ICH guidance including E3 CSR, E6 (R2) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO14971.
  • Demonstrated ability to work independently and as part of a team. 
  • Ability to interact with physicians in a professional manner. 
  • Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.
  • Advanced skills using Microsoft Office products such as Outlook, Word, Excel and Power Point
Minimum Requirements:
  • Bachelor’s or Master’s degree in a relevant scientific discipline, or equivalent.
  • 5+ years’ experience as a medical writer,
  • 3+ years’ direct experience working on clinical evaluations within the Medical Device industry.
  • Medical writing certification a plus.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

 

#LI-DV1

#CBD#

We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.

CHECK OUT OUR SIMILAR JOBS

  1. Editor Jobs
  2. Technical Writer Jobs