Senior Medical Writer

Role : Medical Writer
Location : Hyderabad
Yrs of exp : 8 yrs - 14 yrs

Primary role:
Responsible for creation and update of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) of Medical Devices as per MEDDEV Rev 4 and MDR regulations.
Should have experience in handling reports such as Subject Device and State of the Art Literature Reports, Post Market Surveillance (PMS Plan), Post Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Post-market clinical follow-up (PMCF) Plan and Post-market clinical follow-up Report and Summary of safety and clinical performance (SSCP)
Team Handling and Management
Act as SME for deliverables
Conducting trainings and mentoring sessions to upskill the resources
Responsible for assessing the effort estimation for clinical projects
Support the Project/ Delivery Manager in driving the project related activities such as timelines, SOWs etc,
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RESPONSIBILITIES
Author and maintain Clinical Evaluation Plans/Reports (CEPS/CERs) in compliance with EU MDR (2017/745), Article 61 & Annex XIV
Strong experience authoring PMSP/ PMCFP/ PMSR/ PSUR/ PMCFER/ SSCP documents
Strong knowledge of EU MDR, MEDDEV 2.7/1 Rev.4 and MDCG guidance
Perform systematic literature reviews and critical appraisal of clinical evidence
Assess clinical data from literature, clinical investigations, PMS and PMCF
Establish State of the Art (SOTA) and support benefit–risk evaluations
Ensure consistency of CERs with Risk Management, PMS/PMCF, IFU, SSCP, and Technical Documentation
Support Notified Body deficiency responses
Experience with Class I/ IIa/IIb/III medical devices and implantable
Strong analytical and attention to detail skills
Ability to work directly with clients
Team Management and Project leading capabilities
Effective cross functional collaboration and ownership mindset
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QUALIFICATIONS
Education: Graduate or post graduate degree in life sciences

Minimum Work Experience:
8 to 12+ years of total experience, of which 8+ years of relevant work experience in Clinical Evaluation documents writing is recommended.
Skills:
Personal qualities include the ability to gain trust and confidence with a variety of clients as well as within HCL, good learning ability, action oriented and resilience in a fast-paced and rapidly changing environment.
Effective communication skills that include the provision of timely and accurate information to stakeholders, strong written and oral communication skills, computer literate: MS Office.
Exceptional hold over proofreading and grammatical skills.
Experience in using databases/ tools such as EndNote, OVID/ EMBASE/PubMed, DistillerSR, PerfectIt, Grammarly
Demonstrated ability in the following areas: Excellent communication skills, both verbal and written, effective interpersonal skills, ability to work independently and collaboratively on project teams, interface with investigative sites, and recognize safety and efficacy data trends.
Attributes: Self-motivated and motivational, self-starter, positive team player, adaptable, willing to travel, as needed.

Qualifications:
- Any Master's or Bachelor's degree in Life Sciences – B. Pharm, M. Pharm, PharmD, Medical Microbiology, Biotechnology, Pharmaceutical Engineering.
- Basic understanding of human anatomy and physiology is preferable. Knowledge of disease pathology and their treatment is an advantage.
- Good understanding of MDCG, MEDDEV 2.7/1 Rev 4 and EU MDR
- Good grasp over medical writing techniques is eminent.

Interested candidate can share their cv over
samiksha.gedam@hcltech.com